Solid TumorsPhase 1NCT00502892
Topotecan, Ifosfamide and Carboplatin in Children and Young Adults With Solid Tumors
A Phase 1 study testing Topotecan, Ifosfamide and Carboplatin in people with Solid Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: To determine the maximum tolerated dose (MTD) of Topotecan when added to a fixed dose regimen of Ifosfamide and Carboplatin in children and young adults with solid tumors. Read more about this study
- Who is it for?
- Ages Up to 45 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Topotecan, Ifosfamide and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Jan 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age </= 45years.
- Histologic proof of solid tumor malignancy (excluding brain stem tumors) at initial diagnosis. Diagnostic Categories include: a) Sarcoma (Soft Tissue and Bone), b) Kidney Tumors, c) Brain Tumors, d) Neuroblastoma, e) Hodgkin's disease and non-Hodgkin's lymphoma, f) Other solid tumors (gonadal and germ cell tumors, malignant melanoma, retinoblastoma, liver tumors, and miscellaneous tumors)
- If previously treated, must have radiographic, nuclear image, or biopsy proof that they have had a recurrence of their disease within 4 weeks prior to study entry.
- Performance Level: Karnofsky >/= 70% for patients >10 years of age and Lansky Play-Performance Scale >/=70 for children </= 10 years of age. Neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 2 weeks prior to study entry. Patients who are unable to walk because of paralysis, but who are up in a wheelchair will be considered ambulatory for the purpose of assessing the performance score.
- Life Expectancy >/= 8 weeks.
- Full recovery from acute toxic effects of all prior chemo, immuno or XRT: a. No myelosuppressive chemotherapy </=2 weeks (4 weeks if prior nitrosourea). b. At least 7 days since completion of therapy with biologic agent (anti-neoplastic agent). c. No cranial-spinal \&/or spinal (>3600 cGy) XRT. No XRT (including TBI) to > 50% of bone marrow space. d. No evidence of active GVHD. For allogeneic Stem Cell Transplant (SCT), >/= 6 months must have elapsed. e. Has NOT received exact combination \& dosage of Topotecan, Carboplatin, \& Ifosfamide, as this study recommends, within last 3 months.
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- Adequate Bone Marrow Function: ANC >/=1000/ micro L; Platelets >/= 50,000/ micro L (transfusion independent); Hgb >/= 8.0 gm/dL (may receive RBC transfusions).
- Adequate Renal function: Serum creatinine </= 1.5 x normal for age, or Creatinine clearance or radioisotope GFR >/= lower limit of normal for age.
- Adequate Liver function: Total bilirubin </=1.5 x normal for age, and SGPT (ALT) </= 5 x normal for age and albumin >/=2 g/dL.
- Adequate Cardiac Function: Shortening fraction of >/= 27% by echocardiogram, or Ejection fraction of >/= 50% by gated radionuclide study.
- Adequate Pulmonary Function: No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% if there is clinical indication for determination.
- Central Nervous System Function: Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled. CNS toxicity < Grade 2.
- Signed Informed Consent.
Who cannot join
- Pregnancy or Breast Feeding.
- Prior therapy with this particular topotecan, ifosfamide, carboplatin regimen in last 3 months.
- Patients with bone marrow solid tumor involvement.
- Patients having received cranial-spinal and or spinal irradiation (>3600 cGy). Patients who have received radiation therapy (including TBI) to greater than 50% of the bone marrow space.
- Patients with evidence of active graft vs. host disease and/or patients wiht allogeneic Stem Cell Transplant [SCT], < 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase I Study of a Novel Chemotherapeutic Regimen: Topotecan, Ifosfamide and Carboplatin (TIC) in Children and Young Adults With Solid Tumors-- A Limited Multi-Institution Study
Primary Objectives:
- To determine the maximum tolerated dose (MTD) of Topotecan when added to a fixed dose regimen of Ifosfamide and Carboplatin in children and young adults with solid tumors.
- To evaluate the toxicity associated with the administration of Topotecan with Ifosfamide and Carboplatin (TIC) in children and young adults with solid tumors.
Read more
Secondary Objectives:
- To evaluate the duration of neutropenia (ANC<500/micro L) and thrombocytopenia (PLT 50,000/ micro L and 20,000/ micro L) and the number of days of platelet transfusion during each course of TIC chemotherapy when used in conjunction with G-CSF and NEUMEGA in children and young adults with solid tumors.
- To determine the median number of apheresis collections as well as the CD34/kg, CD41/kg, CD61/kg and CD34:41/kg and CD34:61/kg per collection in patients electively undergoing concurrent apheresis for peripheral blood stem cell collection in courses 2 or 3.
- To determine the median number of peripheral blood mononuclear cells (PBMC) and ex-vivo expanded myeloid dendritic cells (DC) in patients electively undergoing concurrent apheresis for PBMC collection in courses 2 or 3.
Read the detailed description
All of the chemotherapy drugs used in this study are FDA approved and commercially available drugs designed to kill cancer cells.
Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a physical exam and routine blood (about 2 teaspoons) and urine tests. You will have electrocardiogram (ECG - test to measure the electrical activity of the heart). You will have a chest x-ray and other scans (such as CT, MRI, Bone, Ultrasound or radionucleotide scans ). You physician will decide which scans are appropriate based on the disease and clinical situation. You will also have a bone marrow aspirate. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. Women who are able to have children must have a negative pregnancy test before starting treatment.
If you are found to be eligible to take part in this study, you will be assigned to a specific dose of topotecan. The first group of participants will receive a smaller dose of topotecan. If patients in that group are able to recover a sufficient number of platelets by Day 22 and no severe side effects are experienced, the next group of participants will be treated with a larger dose topotecan. The dose will continue to be increased for each new group of participants until all the participants in a dose group are unable to recover a sufficient number of platelets by Day 22, or until severe side effects are experienced. There will be 3 patients in each group. The doses of all the other drugs used on this study will be the same for every participants.
Topotecan, ifosfamide, and carboplatin will be given for the first three days of each course. Ifosfamide and carboplatin will be given into a vein for one hour each day along with the drug mesna. Mesna is not an anti-cancer drug but a drug to help protect the bladder from the potential damaging effects of ifosfamide. After the first dose of mesna, participants will receive 3 more doses (one every three hours) over 15-30 minutes . Topotecan is given directly into a vein for one-half hour beginning one hour after treatment with ifosfamide, carboplatin, and the first dose of mesna is completed. Participants who are 22 years or older will only receive Day 1 and 2 of carboplatin.
Starting on the fourth day of each course, you will be given a daily injection of the drug Filgrastim. Filgrastim is a growth factor naturally produced in the body to stimulate the production of white blood cells (infection fighting cells). Filgrastim can now be produced in the laboratory and given to patients at higher doses than the body makes. Filgrastim should help the body recover from treatment. Filgrastim will be given as an injection under the skin once a day until an acceptable number of white blood cells are detected in the bloodstream.
A second course of chemotherapy will begin as soon as 21 days after the start of treatment as long as you have recovered enough white blood cells and platelets. If the white blood cells and platelets have not recovered by 21 days, you will begin the next course when they do recover.
After each of the first three courses, you will have a re-evaluation of the disease. Re-evaluation will require the same scans to be performed as were done at study entry. If the tumor shows a complete or partial response to the treatment after the second course, then continuation on the study will be at the discretion of the treating physician. If the disease is stable, meaning there is no change in the size or degree of the tumor, then treatment can continue for a total of 3 courses overall.
If the disease gets worse or intolerable side effects occur, you will be taken off study and other treatment options will be discussed with you.
You may need to be hospitalized during the first three days of each chemotherapy course and will require visits as an outpatient at other times during treatment to receive laboratory follow-up and evaluation. Participants may also require hospitalization because of side effects.
During treatment, you will have a physical exam and routine blood (about 2 teaspoons) and urine tests. You will also have an ECG, a chest x-ray, and other scans as thought necessary. The physical exam will be done once a week for Courses 1 - 3. The blood tests will be done on Days 1, 3, 5; then twice weekly and on Day 22 of each course. Urine tests will be done on Day 1 of each course and at the end of Course 2. The scans and ECG will be performed at the end of each course or sooner if it is suspected that the disease has gotten worse.
This is an investigational study. The drugs on this study are FDA approved and commercially available. However, their use together in this study is experimental. Up to 78 patients will take part in this study. About 15 patients will be enrolled at UTMDACC.
- Conditions
- Solid Tumors
- Being tested
- Topotecan, Ifosfamide, Carboplatin
- Keywords
- Solid Tumors, Topotecan, Hycamtin, Ifosfamide, Ifex, Carboplatin, Paraplatin, Pediatric, Children, Young Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopotecanDrug
Also called Hycamtin
0.5 mg/m^2 IV Daily x 3 Days
IfosfamideDrug
Also called Ifex
1.8 grams/m^2 IV Over 1 Hour x 5 Days
CarboplatinDrug
Also called Paraplatin
AUC = 3 mg/ml/min IV Over 1 Hour x 3 Days [for patients > 22 yrs of age, 3 mg/mL/min IV Over 1 Hour x 2 Days]
| Study group | Role | What they receive |
|---|---|---|
| Topotecan + Ifosfamide + Carboplatin | Experimental | Not described Receives: Drug: Topotecan; Drug: Ifosfamide; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Measured: Blood tests on Days 1, 3, 5, then twice weekly and on Day 22 of each course; Urine tests done on Day 1 of each course and at end of Course 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startAug 2004
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert J. Wells, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502892
- Sponsor's protocol ID
- 2004-0079
- Status last verified
- Jul 2012
- First submitted
- 16 Jul 2007
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of a Novel Chemotherapeutic Regimen: Topotecan, Ifosfamide and Carboplatin (TIC) in Children and Young Adults With Solid Tumors-- A Limited Multi-Institution Study
- ClinicalTrials.gov ID
- NCT00502892
- Acronym / sponsor ID
- 2004-0079
- Conditions
- Solid Tumors
- Keywords
- Solid Tumors, Topotecan, Hycamtin, Ifosfamide, Ifex, Carboplatin, Paraplatin, Pediatric
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 18 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- To determine the maximum tolerated dose (MTD) of Topotecan when added to a fixed dose regimen of Ifosfamide and Carboplatin in children and young adults with solid tumors.
- To evaluate the toxicity associated with the administration of Topotecan with Ifosfamide and Carboplatin (TIC) in children and young adults with solid tumors.
Secondary Objectives:
- To evaluate the duration of neutropenia (ANC<500/micro L) and thrombocytopenia (PLT 50,000/ micro L and 20,000/ micro L) and the number of days of platelet transfusion during each course of TIC chemotherapy when used in conjunction with G-CSF and NEUMEGA in children and young adults with solid tumors.
- To determine the median number of apheresis collections as well as the CD34/kg, CD41/kg, CD61/kg and CD34:41/kg and CD34:61/kg per collection in patients electively undergoing concurrent apheresis for peripheral blood stem cell collection in courses 2 or 3.
- To determine the median number of peripheral blood mononuclear cells (PBMC) and ex-vivo expanded myeloid dendritic cells (DC) in patients electively undergoing concurrent apheresis for PBMC collection in courses 2 or 3.
Detailed description
All of the chemotherapy drugs used in this study are FDA approved and commercially available drugs designed to kill cancer cells.
Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a physical exam and routine blood (about 2 teaspoons) and urine tests. You will have electrocardiogram (ECG - test to measure the electrical activity of the heart). You will have a chest x-ray and other scans (such as CT, MRI, Bone, Ultrasound or radionucleotide scans ). You physician will decide which scans are appropriate based on the disease and clinical situation. You will also have a bone marrow aspirate. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. Women who are able to have children must have a negative pregnancy test before starting treatment.
If you are found to be eligible to take part in this study, you will be assigned to a specific dose of topotecan. The first group of participants will receive a smaller dose of topotecan. If patients in that group are able to recover a sufficient number of platelets by Day 22 and no severe side effects are experienced, the next group of participants will be treated with a larger dose topotecan. The dose will continue to be increased for each new group of participants until all the participants in a dose group are unable to recover a sufficient number of platelets by Day 22, or until severe side effects are experienced. There will be 3 patients in each group. The doses of all the other drugs used on this study will be the same for every participants.
Topotecan, ifosfamide, and carboplatin will be given for the first three days of each course. Ifosfamide and carboplatin will be given into a vein for one hour each day along with the drug mesna. Mesna is not an anti-cancer drug but a drug to help protect the bladder from the potential damaging effects of ifosfamide. After the first dose of mesna, participants will receive 3 more doses (one every three hours) over 15-30 minutes . Topotecan is given directly into a vein for one-half hour beginning one hour after treatment with ifosfamide, carboplatin, and the first dose of mesna is completed. Participants who are 22 years or older will only receive Day 1 and 2 of carboplatin.
Starting on the fourth day of each course, you will be given a daily injection of the drug Filgrastim. Filgrastim is a growth factor naturally produced in the body to stimulate the production of white blood cells (infection fighting cells). Filgrastim can now be produced in the laboratory and given to patients at higher doses than the body makes. Filgrastim should help the body recover from treatment. Filgrastim will be given as an injection under the skin once a day until an acceptable number of white blood cells are detected in the bloodstream.
A second course of chemotherapy will begin as soon as 21 days after the start of treatment as long as you have recovered enough white blood cells and platelets. If the white blood cells and platelets have not recovered by 21 days, you will begin the next course when they do recover.
After each of the first three courses, you will have a re-evaluation of the disease. Re-evaluation will require the same scans to be performed as were done at study entry. If the tumor shows a complete or partial response to the treatment after the second course, then continuation on the study will be at the discretion of the treating physician. If the disease is stable, meaning there is no change in the size or degree of the tumor, then treatment can continue for a total of 3 courses overall.
If the disease gets worse or intolerable side effects occur, you will be taken off study and other treatment options will be discussed with you.
You may need to be hospitalized during the first three days of each chemotherapy course and will require visits as an outpatient at other times during treatment to receive laboratory follow-up and evaluation. Participants may also require hospitalization because of side effects.
During treatment, you will have a physical exam and routine blood (about 2 teaspoons) and urine tests. You will also have an ECG, a chest x-ray, and other scans as thought necessary. The physical exam will be done once a week for Courses 1 - 3. The blood tests will be done on Days 1, 3, 5; then twice weekly and on Day 22 of each course. Urine tests will be done on Day 1 of each course and at the end of Course 2. The scans and ECG will be performed at the end of each course or sooner if it is suspected that the disease has gotten worse.
This is an investigational study. The drugs on this study are FDA approved and commercially available. However, their use together in this study is experimental. Up to 78 patients will take part in this study. About 15 patients will be enrolled at UTMDACC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topotecan + Ifosfamide + Carboplatin | Experimental | Drug: Topotecan, Drug: Ifosfamide, Drug: Carboplatin |
Who may qualify
- Ages
- Up to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Age </= 45years.
- Histologic proof of solid tumor malignancy (excluding brain stem tumors) at initial diagnosis. Diagnostic Categories include: a) Sarcoma (Soft Tissue and Bone), b) Kidney Tumors, c) Brain Tumors, d) Neuroblastoma, e) Hodgkin's disease and non-Hodgkin's lymphoma, f) Other solid tumors (gonadal and germ cell tumors, malignant melanoma, retinoblastoma, liver tumors, and miscellaneous tumors)
- If previously treated, must have radiographic, nuclear image, or biopsy proof that they have had a recurrence of their disease within 4 weeks prior to study entry.
- Performance Level: Karnofsky >/= 70% for patients >10 years of age and Lansky Play-Performance Scale >/=70 for children </= 10 years of age. Neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 2 weeks prior to study entry. Patients who are unable to walk because of paralysis, but who are up in a wheelchair will be considered ambulatory for the purpose of assessing the performance score.
- Life Expectancy >/= 8 weeks.
Key exclusion criteria (5 listed)
- Pregnancy or Breast Feeding.
- Prior therapy with this particular topotecan, ifosfamide, carboplatin regimen in last 3 months.
- Patients with bone marrow solid tumor involvement.
- Patients having received cranial-spinal and or spinal irradiation (>3600 cGy). Patients who have received radiation therapy (including TBI) to greater than 50% of the bone marrow space.
- Patients with evidence of active graft vs. host disease and/or patients wiht allogeneic Stem Cell Transplant [SCT], < 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TopotecanAlso: Hycamtin0.5 mg/m^2 IV Daily x 3 Days | Drug | Topotecan + Ifosfamide + Carboplatin |
| IfosfamideAlso: Ifex1.8 grams/m^2 IV Over 1 Hour x 5 Days | Drug | Topotecan + Ifosfamide + Carboplatin |
| CarboplatinAlso: ParaplatinAUC = 3 mg/ml/min IV Over 1 Hour x 3 Days [for patients > 22 yrs of age, 3 mg/mL/min IV Over 1 Hour x 2 Days] | Drug | Topotecan + Ifosfamide + Carboplatin |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Blood tests on Days 1, 3, 5, then twice weekly and on Day 22 of each course; Urine tests done on Day 1 of each course and at end of Course 2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J. Wells, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Topotecan, Ifosfamide and Carboplatin in people with Solid Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: Blood tests on Days 1, 3, 5, then twice weekly and on Day 22 of each course; Urine tests done on Day 1 of each course and at end of Course 2.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2012.