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.

Sponsors and Collaborators: National Cancer Institute (NCI)
H. Lee Moffitt Cancer Center and Research Institute
Information provided by: National Cancer Institute (NCI)

Purpose

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
 Drug: cisplatin
 Drug: cyclophosphamide
 Drug: cytarabine
 Drug: dexamethasone
 Drug: etoposide
 Drug: fludarabine
 Drug: methylprednisolone
 Drug: mitoxantrone
Phase II

MedlinePlus related topics:  Hodgkin's Disease;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Allogeneic vs Autologous Stem Cell Transplantation in Patients With High Risk Non-Hodgkin's Lymphoma or Hodgkin's Disease

Further Study Details: 

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.

Eligibility

Ages Eligible for Study:  15 Years   -   55 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

[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.]

--Prior/Concurrent Therapy--

  • See Disease Characteristics

--Patient 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

Location Information


Florida
      Florida Cancer Specialists, Fort Myers,  Florida,  33901,  United States

      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612,  United States

Study chairs or principal investigators

Steven C. Goldstein,  Study Chair,  H. Lee Moffitt Cancer Center and Research Institute   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067743; MCC-11306; NCI-G00-1746; MCC-IRB-4250
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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005