Clinical Trial: Peripheral Stem Cell Transplantation Plus Combination Chemotherapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

This study is no longer recruiting patients.

Sponsored by: University of Maryland Greenebaum Cancer Center
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 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 study the effectiveness of peripheral stem cell transplantation plus combination chemotherapy in treating patients who have low-grade non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Condition Treatment or Intervention Phase
Lymphocytic Lymphoma
 Drug: carmustine
 Drug: cisplatin
 Drug: cyclophosphamide
 Drug: dexamethasone
 Drug: etoposide
 Drug: melphalan
 Drug: paclitaxel
Phase II

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Autologous Transplantation Using High Dose Carmustine and Melphalan Followed by Consolidation with Dexamethasone/Cyclophosphamide/Etoposide/Cisplatin Plus Dexamethasone, Paclitaxel, and Cisplatin in Patients with Poor Prognosis Low Grade Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

Further Study Details: 

Study start: January 1999

OBJECTIVES: I. Evaluate the complete and partial response rates to treatment with peripheral blood stem cell supported high dose carmustine and melphalan followed by consolidation therapy with dexamethasone/cyclophosphamide/etoposide/cisplatin (DCEP) and dexamethasone, paclitaxel, and cisplatin in patients with poor prognosis low grade non-Hodgkin's lymphoma or chronic lymphocytic leukemia and no greater than 12 months of prior standard therapy. II. Evaluate the incidence of early deaths (less than 60 days posttransplant) in comparison with historical experience in this patient population. III. Evaluate the toxicity of posttransplantation chemotherapy with DCEP and dexamethasone, paclitaxel, and cisplatin in these patients.

PROTOCOL OUTLINE: Patients receive carmustine IV over 2 hours on day -2 and melphalan IV on day -1 followed by peripheral blood stem cell infusion on day 0. At 3 months and 9 months after completion of autologous transplantation, patients receive cyclophosphamide, etoposide, and cisplatin by continuous IV infusion for 4 days plus dexamethasone orally every day for 4 days. At 6 and 12 months after completion of autologous transplantation, patients receive dexamethasone orally every day for 4 days, paclitaxel continuous IV infusion over 6 hours on day 2, and cisplatin continuous IV infusion over 24 hours on day 3.

PROJECTED ACCRUAL: There will be 12-35 patients accrued into this study over 1-2.5 years.

Eligibility

Ages Eligible for Study:  18 Years   -   70 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Histologically confirmed low grade follicular lymphoma, mantle cell lymphoma, or chronic lymphocytic leukemia with no greater than 12 months of prior standard therapy
  • Follicular lymphoma; Must have poor prognosis disease defined as any of the following: Any nodal or extranodal tumor mass with a diameter more than 7 cm; Involvement of at least 3 nodal sites, each of which has a diameter greater than 3 cm Systemic symptoms; Substantial splenic involvement no greater than 5 cm below left costal margin; Serous effusions (ascites, pleural or pericardial effusions); Orbital or epidural involvement; Ureteral compression; Leukemia presentation (at least 500/microliter); Increased LDH level; Greater than 20% bone marrow involvement
  • Mantle cell lymphoma No mantle zone morphology
  • Chronic lymphocytic leukemia; Must have either anemia (hemoglobin less than 10 g/dL), thrombocytopenia (less than 100,000/mm3), cytogenetic abnormalities including +12 and 11q, elevated LDH levels, labeling index at least 2%, systemic symptoms, or hepatosplenomegaly
  • 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.]

--Prior/Concurrent Therapy--

  • Biologic therapy: Not specified
  • Chemotherapy: At least 4 weeks since prior chemotherapy
  • Endocrine therapy: Prior corticosteroids allowed
  • Radiotherapy: At least 4 weeks since prior local radiotherapy
  • Surgery: Not specified

--Patient Characteristics--

  • Age: 18 to 70
  • Performance status: SWOG 0-2
  • Life expectancy: Not specified
  • Hematopoietic: At least 4,000/g CD34+ peripheral blood stem cells available; See Disease Characteristics
  • Hepatic: Bilirubin no greater than 1.5 mg/dL; Transaminases no greater than 4 times upper limit of normal; No active chronic hepatitis or liver cirrhosis
  • Renal: Creatinine no greater than 2.0 mg/dL
  • Cardiovascular: Left ventricular ejection fraction at least 50%
  • Pulmonary: FEV1, FVC, and DLCO at least 50% of predicted
  • Other: HIV negative; No active infection requiring intravenous antibiotics; Not pregnant or nursing; Effective contraception required of all fertile patients

Location Information


Maryland
      Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201,  United States

Study chairs or principal investigators

Barry R. Meisenberg,  Study Chair,  University of Maryland Greenebaum Cancer Center   

More Information

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

Study ID Numbers:  CDR0000066407; MSGCC-9734; NCI-V98-1439
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003402
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


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

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