Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease - Article
Clinical Trial: Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease
This study is no longer recruiting patients.
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to compare the effectiveness of allogeneic stem cell transplantation with that of autologous peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma or Hodgkin's disease.
|Condition||Treatment or Intervention||Phase|
|recurrent diffuse small lymphocytic/marginal zone lymphoma |
recurrent adult diffuse small cleaved cell lymphoma
recurrent grade III follicular large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent mantle cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult Hodgkin's disease
recurrent grade I follicular small cleaved cell lymphoma
recurrent grade II follicular mixed cell lymphoma
stage III adult Hodgkin's disease
stage IV adult Hodgkin's disease
| Drug: carmustine |
|Phase II |
MedlinePlus related topics: Hodgkin's Disease; Lymphoma
Study Type: Interventional
Study Design: Treatment
Study start: March 2000
OBJECTIVES: I. Compare the relapse rate, progression free survival, and overall survival in patients with high risk non-Hodgkin's lymphoma or Hodgkin's disease treated with allogeneic vs autologous stem cell transplantation.
II. Compare the toxicities (short and long term) of these 2 regimens in these patients.
PROTOCOL OUTLINE: Cytoreductive therapy: Patients receive 3 courses of salvage chemotherapy (e.g., dexamethasone, high dose cytarabine, and cisplatin (DHAP); etoposide, methylprednisolone, high dose cytarabine, and cisplatin (ESHAP); fludarabine, mitoxantrone, and dexamethasone (FND)).
Harvest: Patients with an HLA identical sibling donor are assigned to the allogeneic peripheral blood stem cell (PBSC) transplantation group. Patients without an HLA identical sibling are assigned to the autologous PBSC transplantation group. Allogeneic OR autologous PBSC are harvested.
Conditioning regimen: Patients receive high dose chemotherapy comprised of cyclophosphamide IV over 1 hour on days -6 to -3 and carmustine IV over 3 hours and etoposide IV over 3 hours on days -6 to -4. PBSC are infused on day 0.
Patients are followed weekly for 3 months, then monthly for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study over 4 years.
Ages Eligible for Study: 15 Years - 55 Years
PROTOCOL ENTRY CRITERIA:
- Histologically proven non-Hodgkin's lymphoma that has relapsed or failed to achieve complete remission after first line induction chemotherapy; Intermediate or high grade (including mantle cell, but excluding lymphoblastic disease); No more than 1 prior salvage chemotherapy regimen, e.g.: Dexamethasone, high dose cytarabine, and cisplatin (DHAP); Etoposide, methylprednisolone, high dose cytarabine, and cisplatin (ESHAP); Low grade; No more than 2 prior salvage chemotherapy regimens, e.g.: Fludarabine, mitoxantrone, and dexamethasone (FND); ESHAP; DHAP OR
- Histologically proven stage III or IV Hodgkin's disease that has relapsed or failed to achieve remission after combination induction chemotherapy; Prior primary radiotherapy allowed if relapse is high risk (e.g., recurrence in radiation field, B symptoms, liver/marrow involvement); No more than 2 prior salvage chemotherapy regimens
- Allogeneic stem cell transplantation group: Availability of 6 antigen (A, B, and DR loci) HLA matched sibling donor
- No active CNS disease
[A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.]
- See Disease Characteristics
- Age: 15 to 55
- Performance status: ECOG 0 or 1
- Life expectancy: Not specified
- Hematopoietic: Not specified
- Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT and SGPT no greater than 3 times normal; PT and PTT normal
- Renal: Creatinine no greater than 2.0 mg/dL; Creatinine clearance at least 60 mL/min
- Cardiovascular: LVEF at least 45% by MUGA scan or echocardiogram; No myocardial infarction within the past 6 months; No arrhythmias unless medically controlled
- Pulmonary: FEV1 at least 50% predicted; DLCO at least 50% predicted
- Other: No diabetes mellitus or thyroid disease unless medically controlled; No active serious infection; HIV negative; Not pregnant or nursing; Negative pregnancy test
Florida Cancer Specialists, Fort Myers, Florida, 33901, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, 33612, United States
Steven C. Goldstein, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
Record last reviewed: June 2004
Last Updated: October 13, 2004
Record first received: May 2, 2000
ClinicalTrials.gov Identifier: NCT00005613
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005