Clinical Trial: Combination Chemotherapy and Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma

This study is no longer recruiting patients.

Sponsored by: Fox Chase Cancer Center
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow and peripheral stem cell transplantation may allow doctors to give high doses of chemotherapy and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with cyclophosphamide, etoposide and cisplatin followed by bone marrow and/or peripheral stem cell transplantation in patients with relapsed or refractoryintermediate- or high-grade non-Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
adult Burkitt's lymphoma
adult diffuse large cell lymphoma
adult diffuse mixed cell lymphoma
adult diffuse small cleaved cell lymphoma
adult immunoblastic large cell lymphoma
adult lymphoblastic lymphoma
 Drug: cisplatin
 Drug: cyclophosphamide
 Drug: etoposide
 Procedure: autologous bone marrow transplantation
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: bone marrow transplantation
 Procedure: chemotherapy
 Procedure: high-dose chemotherapy
 Procedure: peripheral blood stem cell transplantation
 Procedure: radiation therapy
 Procedure: syngeneic bone marrow transplantation
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lymphoma;   Viral Infections

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of High-Dose Cyclophosphamide, Etoposide, and Cisplatin (CEP) With Syngeneic or Autologous Bone Marrow and/or Autologous Peripheral Blood Stem Cell Rescue in Patients With Relapsed or Refractory, Stage I-IV, Intermediate- or High-Grade Non-Hodgkin's Lymphoma

Further Study Details: 

OBJECTIVES:

OUTLINE: Syngeneic or autologous bone marrow and/or autologous peripheral blood stem cells (PBSC) are harvested. Syngeneic bone marrow transplantation is preferred for patients with a qualifying identical twin donor. Patients without a syngeneic donor who have a history of lymphomatous involvement of the bone marrow and are profoundly hypocellular undergo harvest of PBSC alone. Patients without a syngeneic donor who have no history of lymphomatous involvement of the bone marrow undergo harvest of autologous bone marrow or PBSC.

Patients receive conditioning comprising cyclophosphamide IV over 1 hour on days -6 to -3 and etoposide IV over 1 hour every 12 hours and cisplatin IV continuously on days -6 to -4. Bone marrow and/or PBSC are infused on day 0. (Patients requiring more than 25 bags of stem cells receive bone marrow transplantation on day 0 and PBSC transplantation on day 1.)

After recovery from transplantation, eligible patients receive consolidative radiotherapy to any site of prior bulk disease (greater than 5 cm) present at any time before transplantation and any site of disease present at the time of transplantation.

Patients are followed at 3, 6, and 12 months and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  15 Years   -   60 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven relapsed or refractory, stage I-IV, intermediate- or high-grade non-Hodgkin's lymphoma
  • Eligible subtypes:
  • Diffuse small cleaved cell
  • Diffuse mixed (small and large cell)
  • Diffuse large cell
  • Large cell immunoblastic
  • Lymphoblastic
  • Small noncleaved cell
  • High-grade histology patients should first be considered for Protocol TUHSC-1520
  • Must have chemosensitive disease, defined by 1 of the following conditions:
  • Response to initial chemotherapy without obtaining complete response (CR)(refractory lymphoma)
  • Relapse after chemotherapy-induced CR if tumor volume reduced by at least 25% for more than 1 month after completion of 1-3 courses of salvage chemotherapy (chemosensitive relapse)
  • No chemoresistant disease, defined by the following conditions:
  • Unresponsive or progressive disease during initial chemotherapy
  • Relapse after chemotherapy-induced CR if tumor volume not reduced by at least 25% after completion of 1-3 courses salvage chemotherapy (chemoresistant relapse)
  • No CNS involvement by lymphoma
  • Syngeneic bone marrow transplantation offered to patients with consenting identical twin donor NOTE: 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.

PATIENT CHARACTERISTICS: Age:

  • 15 to 60 (physically fit patients up to age 70 may be considered)

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • AST and ALT not persistently greater than 2 times normal

Renal:

  • Creatinine less than 1.8 mg/dL

Cardiovascular:

  • Cardiac ejection fraction at least 45%

Pulmonary:

  • DLCO, FEV_1, and FVC at least 50% predicted
  • Resting pO_2 at least 70 mm Hg

Other:

  • HIV negative
  • No other concurrent disease that would limit life expectancy
  • No active infection
  • No severe neurologic or emotional disorders
  • Not pregnant
  • Fertile patients must use effective contraception
  • Adequate psychological support available

PRIOR CONCURRENT THERAPY: Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Location Information


Pennsylvania
      Fox Chase - Temple Cancer Center, Philadelphia,  Pennsylvania,  19111-2442,  United States

Study chairs or principal investigators

Kenneth F. Mangan, MD,  Study Chair,  Fox Chase Cancer Center   

More Information

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

Study ID Numbers:  CDR0000078282; TUHSC-2161; NCI-V93-0248
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002521
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


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