LymphomaPhase 2NCT00003143
Combination Chemotherapy With or Without Amifostine in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or Hodgkin's Disease Undergoing Stem Cell Transplantation
A Phase 2 study testing Amifostine and DHAP in people with Lymphoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Amifostine and DHAP
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1997to Dec 2000
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory non-Hodgkin's lymphoma or Hodgkin's disease requiring salvage chemotherapy Prior treatment with at least 3 courses of first line chemotherapy
PATIENT CHARACTERISTICS: Age: Over 18 Performance Status: ECOG 0-2 Life Expectancy: Greater than 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 50,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 40 mL/min Cardiovascular: No symptomatic congestive heart failure (class III or more as defined by American Heart Association) Electrolytes: Potassium at least 3.4 meq/L Magnesium at least 1.4 meq/L Other: Not pregnant or nursing
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior high dose chemotherapy with stem cell transplant At least 3 courses of first line chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
About this study
Official title: A Randomized Study of Ethyol (Amifostine) With Platinum Based Salvage Chemotherapy in Patients With Lymphoma Undergoing Autologous Stem Cell Transplantation
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.
PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy with or without amifostine in treating patients with recurrent or refractory non-Hodgkin's lymphoma or Hodgkin's disease who are undergoing autologous stem cell transplantation.
Read the detailed description
OBJECTIVES: I. Evaluate the role of amifostine in reducing hematologic toxicity and improving mobilization of peripheral progenitor stem cells in patients with recurrent or refractory non-Hodgkin's lymphoma or Hodgkin's disease who are undergoing platinum based salvage chemotherapy. II. Evaluate the role of amifostine in preventing renal toxicity in these patients.
OUTLINE: This is an randomized, open label study. Patients are randomized to receive salvage chemotherapy with intravenous dexamethasone/cisplatin/cytarabine (DHAP) with or without amifostine. Patients receive cisplatin IV over 3 hours followed by cytarabine IV for 2 doses. Patients also receive dexamethasone orally or IV. Treatment repeats every 3-4 weeks for 2-6 courses. Arm I: Patients receive amifostine IV over 15 minutes prior to all courses of DHAP, as a 15 minute infusion, beginning 30 minutes prior to cisplatin administration. Arm II: Patients do not receive amifostine. On day 3 of the last DHAP course, patients receive filgrastim (G-CSF) until the last day of progenitor stem cell (PSC) mobilization. PSC transplant continues daily for 4-10 days.
PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this study.
- Conditions
- Lymphoma
- Being tested
- Amifostine, DHAP
- Keywords
- recurrent adult Hodgkin lymphoma, Waldenström macroglobulinemia, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma
- Medical subject headings
- Lymphoma, Hodgkin Disease, Waldenstrom Macroglobulinemia, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmifostineDrug
DHAPDrug
| Study group | Role | What they receive |
|---|---|---|
| DHAP + amifostine | Experimental | Patients are randomized to receive salvage chemotherapy with intravenous dexamethasone/cisplatin/cytarabine (DHAP) with or without amifostine. Patients receive cisplatin IV over 3 hours followed by cytarabine IV for 2 doses. Patients also receive dexamethasone orally or IV. Treatment repeats every 3-4 weeks for 2-6 courses. Arm I: Patients receive amifostine IV over 15 minutes prior to all courses of DHAP, as a 15 minute infusion, beginning 30 minutes prior to cisplatin administration. Arm II: Patients do not receive amifostine. On day 3 of the last DHAP course, patients receive filgrastim (G-CSF) until the last day of progenitor stem cell (PSC) mobilization. PSC transplant continues daily for 4-10 days. Receives: Drug: Amifostine; Drug: DHAP |
| DHAP | Other | Patients are randomized to receive salvage chemotherapy with intravenous dexamethasone/cisplatin/cytarabine (DHAP) with or without amifostine. Patients receive cisplatin IV over 3 hours followed by cytarabine IV for 2 doses. Patients also receive dexamethasone orally or IV. Treatment repeats every 3-4 weeks for 2-6 courses. Arm I: Patients receive amifostine IV over 15 minutes prior to all courses of DHAP, as a 15 minute infusion, beginning 30 minutes prior to cisplatin administration. Arm II: Patients do not receive amifostine. On day 3 of the last DHAP course, patients receive filgrastim (G-CSF) until the last day of progenitor stem cell (PSC) mobilization. PSC transplant continues daily for 4-10 days. Receives: Drug: DHAP |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2004 (estimated)
- Study startNov 1997
- Primary completionDec 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christos E. Emmanouilides, MD, Study chair, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003143
- Sponsor's protocol ID
- CDR0000065926
- Other IDs
- UCLA-HSPC-970708701, ALZA-UCLA-HSPC-970708701, NCI-V97-1362
- Status last verified
- Oct 2012
- First submitted
- 1 Nov 1999
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Ethyol (Amifostine) With Platinum Based Salvage Chemotherapy in Patients With Lymphoma Undergoing Autologous Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00003143
- Acronym / sponsor ID
- CDR0000065926
- Conditions
- Lymphoma
- Keywords
- recurrent adult Hodgkin lymphoma, Waldenström macroglobulinemia, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Nov 1997
- Primary completion
- Dec 2000 (actual)
- First posted
- 16 Jun 2004 (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 cancer cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.
PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy with or without amifostine in treating patients with recurrent or refractory non-Hodgkin's lymphoma or Hodgkin's disease who are undergoing autologous stem cell transplantation.
Detailed description
OBJECTIVES: I. Evaluate the role of amifostine in reducing hematologic toxicity and improving mobilization of peripheral progenitor stem cells in patients with recurrent or refractory non-Hodgkin's lymphoma or Hodgkin's disease who are undergoing platinum based salvage chemotherapy. II. Evaluate the role of amifostine in preventing renal toxicity in these patients.
OUTLINE: This is an randomized, open label study. Patients are randomized to receive salvage chemotherapy with intravenous dexamethasone/cisplatin/cytarabine (DHAP) with or without amifostine. Patients receive cisplatin IV over 3 hours followed by cytarabine IV for 2 doses. Patients also receive dexamethasone orally or IV. Treatment repeats every 3-4 weeks for 2-6 courses. Arm I: Patients receive amifostine IV over 15 minutes prior to all courses of DHAP, as a 15 minute infusion, beginning 30 minutes prior to cisplatin administration. Arm II: Patients do not receive amifostine. On day 3 of the last DHAP course, patients receive filgrastim (G-CSF) until the last day of progenitor stem cell (PSC) mobilization. PSC transplant continues daily for 4-10 days.
PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHAP + amifostine | Experimental | Drug: Amifostine, Drug: DHAPPatients are randomized to receive salvage chemotherapy with intravenous dexamethasone/cisplatin/cytarabine (DHAP) with or without amifostine. Patients receive cisplatin IV over 3 hours followed by cytarabine IV for 2 doses. Patients also receive dexamethasone orally or IV. Treatment repeats every 3-4 weeks for 2-6 courses. Arm I: Patients receive amifostine IV over 15 minutes prior to all courses of DHAP, as a 15 minute infusion, beginning 30 minutes prior to cisplatin administration. Arm II: Patients do not receive amifostine. On day 3 of the last DHAP course, patients receive filgrastim (G-CSF) until the last day of progenitor stem cell (PSC) mobilization. PSC transplant continues daily for 4-10 days. |
| DHAP | Other | Drug: DHAPPatients are randomized to receive salvage chemotherapy with intravenous dexamethasone/cisplatin/cytarabine (DHAP) with or without amifostine. Patients receive cisplatin IV over 3 hours followed by cytarabine IV for 2 doses. Patients also receive dexamethasone orally or IV. Treatment repeats every 3-4 weeks for 2-6 courses. Arm I: Patients receive amifostine IV over 15 minutes prior to all courses of DHAP, as a 15 minute infusion, beginning 30 minutes prior to cisplatin administration. Arm II: Patients do not receive amifostine. On day 3 of the last DHAP course, patients receive filgrastim (G-CSF) until the last day of progenitor stem cell (PSC) mobilization. PSC transplant continues daily for 4-10 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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 |
|---|---|---|
| Amifostine | Drug | DHAP + amifostine |
| DHAP | Drug | DHAP, DHAP + amifostine |
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 4 Oct 2012.
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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.
Christos E. Emmanouilides, MD study chair
Jonsson Comprehensive 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 Amifostine and DHAP in people with Lymphoma, run by Jonsson Comprehensive 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 4 Oct 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 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 4 Oct 2012.