Childhood Germ Cell TumorPhase 2NCT00002515
Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer
A Phase 2 study testing filgrastim, carboplatin and thiotepa in people with Childhood Germ Cell Tumor and Extragonadal Germ Cell Tumor, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Head and Neck Cancer
- What is being tested?
- filgrastim, carboplatin and thiotepa
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 1992to Apr 2005
- Phase
- Phase 2
- 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Histologically confirmed malignancy of one of the following types:
- Wilms' tumor
- Liver cancer
- Desmoplastic or other small round cell tumor
- Nasopharyngeal carcinoma
- Fibrosarcoma
- Disease that has metastasized and has a cure rate of no greater than 25% with conventional treatment or disease that has progressed after prior chemotherapy, was not then surgically resectable, and has a salvage rate with nonmyeloablative therapies of no greater than 25% required
- Maximal benefit from conventional (nonmyeloablative) doses of combination chemotherapy required prior to entry, and it is recommended that patients have received a minimum of one of the following:
- 2 courses of high-dose cyclophosphamide (as per protocol MSKCC-90062)
- 2 courses of high-dose ifosfamide/etoposide (as in the poor-risk sarcoma protocol MSKCC-90071A)
- 1 course of high-dose cyclophosphamide plus 1 course of high-dose ifosfamide/etoposide
- Within 3 weeks of initiation of protocol therapy, patients must be:
- In CR or good PR OR
- Tumor considered "chemosensitive", i.e., a 50% or greater decrease in at least 1 measurable tumor parameter attributable to prior chemotherapy without evidence of progressive disease by any other parameter
- Ineligible for other IRB-approved myeloablative regimens
- No evidence of current bone marrow involvement on bone marrow aspiration (x4) and biopsy (x2)
PATIENT CHARACTERISTICS:
Age:
- 21 and under
Performance status:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT no greater than 1.5 times ULN
- Alkaline phosphatase no greater than 1.5 times ULN
- 5'-Nucleotidase no greater than 1.5 times ULN
Renal:
- Creatinine normal
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- CPK normal
- Echocardiogram (or RNCA) normal
- EKG normal
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Myeloablative Chemotherapy With Bone Marrow Rescue For Rare Poor-Prognosis Cancers
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with thiotepa, carboplatin, and topotecan followed by bone marrow transplantation in treating patients who have metastatic or progressive rare cancer.
Read the detailed description
OBJECTIVES:
- Improve the long term disease-free survival of patients with rare cancers at high risk for lethal relapse by using myeloablative chemotherapy with thiotepa, carboplatin, and topotecan followed by autologous bone marrow or peripheral blood stem cell rescue.
OUTLINE: Autologous bone marrow or peripheral blood stem cells (PBSC) are harvested. Patients receive high-dose thiotepa IV over 3 hours on days -8 to -6, carboplatin IV over 4 hours on days -5 to -3, and topotecan IV over 30 minutes on days -8 to -4. Autologous bone marrow or PBSC are reinfused on day 0. Patients receive filgrastim (G-CSF) IV twice daily beginning on day 1.
Patients are followed for 1 year.
PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study within 5 years.
- Conditions
- Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Head and Neck Cancer, Kidney Cancer, Liver Cancer, Lymphoma
- Being tested
- filgrastim, carboplatin, thiotepa, topotecan hydrochloride, autologous bone marrow transplantation
- Keywords
- chondrosarcoma, recurrent childhood rhabdomyosarcoma, stage IV childhood liver cancer, recurrent neuroblastoma, recurrent childhood liver cancer, recurrent Wilms tumor and other childhood kidney tumors, stage IV Wilms tumor, recurrent retinoblastoma, stage IV childhood lymphoblastic lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent osteosarcoma, stage IV ovarian germ cell tumor, recurrent malignant testicular germ cell tumor, childhood germ cell tumor, alveolar childhood rhabdomyosarcoma, recurrent childhood soft tissue sarcoma, recurrent ovarian germ cell tumor, childhood fibrosarcoma, extragonadal germ cell tumor, childhood desmoplastic small round cell tumor
- Medical subject headings
- Head and Neck Neoplasms, Kidney Neoplasms, Liver Neoplasms, Lymphoma, Neuroblastoma, Ovarian Neoplasms, Retinoblastoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
carboplatinDrug
thiotepaDrug
topotecan hydrochlorideDrug
autologous bone marrow transplantationProcedure or surgery
bone marrow ablation with stem cell supportProcedure or surgery
in vitro-treated bone marrow transplantationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startOct 1992
- Primary completionApr 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Germ Cell TumorStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Brian H. Kushner, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002515
- Sponsor's protocol ID
- 92-148
- Other IDs
- CDR0000078115, NCI-V93-0214
- Status last verified
- Jun 2013
- First submitted
- 1 Nov 1999
- Last updated
- 24 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myeloablative Chemotherapy With Bone Marrow Rescue For Rare Poor-Prognosis Cancers
- ClinicalTrials.gov ID
- NCT00002515
- Acronym / sponsor ID
- 92-148
- Conditions
- Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Head and Neck Cancer, Kidney Cancer, Liver Cancer, Lymphoma
- Keywords
- chondrosarcoma, recurrent childhood rhabdomyosarcoma, stage IV childhood liver cancer, recurrent neuroblastoma, recurrent childhood liver cancer, recurrent Wilms tumor and other childhood kidney tumors, stage IV Wilms tumor, recurrent retinoblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Oct 1992
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with thiotepa, carboplatin, and topotecan followed by bone marrow transplantation in treating patients who have metastatic or progressive rare cancer.
Detailed description
OBJECTIVES:
- Improve the long term disease-free survival of patients with rare cancers at high risk for lethal relapse by using myeloablative chemotherapy with thiotepa, carboplatin, and topotecan followed by autologous bone marrow or peripheral blood stem cell rescue.
OUTLINE: Autologous bone marrow or peripheral blood stem cells (PBSC) are harvested. Patients receive high-dose thiotepa IV over 3 hours on days -8 to -6, carboplatin IV over 4 hours on days -5 to -3, and topotecan IV over 30 minutes on days -8 to -4. Autologous bone marrow or PBSC are reinfused on day 0. Patients receive filgrastim (G-CSF) IV twice daily beginning on day 1.
Patients are followed for 1 year.
PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study within 5 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| filgrastim | Biological | – |
| carboplatin | Drug | – |
| thiotepa | Drug | – |
| topotecan hydrochloride | Drug | – |
| autologous bone marrow transplantation | Procedure or surgery | – |
| bone marrow ablation with stem cell support | Procedure or surgery | – |
| in vitro-treated bone marrow transplantation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 24 Jun 2013.
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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.
Brian H. Kushner, MD study chair
Memorial Sloan Kettering 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 2 study testing filgrastim, carboplatin and thiotepa in people with Childhood Germ Cell Tumor and Extragonadal Germ Cell Tumor, run by Memorial Sloan Kettering 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?
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 24 Jun 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 24 Jun 2013.