Peripheral Stem Cell Transplantation Plus Combination Chemotherapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
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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 | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Drug: carmustine Drug: cisplatin Drug: cyclophosphamide Drug: dexamethasone Drug: etoposide Drug: melphalan Drug: paclitaxel Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Autologous Transplantation With and High Dose BCNU and Melphalan Followed by Consolidation With DCEP Plus Taxol/Cisplatin in Patients With Poor Prognosis Low Grade Non-Hodgkin's Lymphoma and Chronic Lymphocyte Leukemia, Who Have Received < or = 12 Months of Standard Therapy |
| Estimated Enrollment: | 35 |
| Study Start Date: | January 1999 |
| Study Completion Date: | December 2002 |
| Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
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.
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 to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
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
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
Contacts and Locations| United States, Maryland | |
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| Study Chair: | Barry R. Meisenberg, MD | University of Maryland Greenebaum Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | UM Greenebaum Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00003402 History of Changes |
| Other Study ID Numbers: | CDR0000066407, MSGCC-9734, NCI-V98-1439 |
| Study First Received: | November 1, 1999 |
| Last Updated: | September 23, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Maryland:
|
Waldenstrom macroglobulinemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia refractory chronic lymphocytic leukemia stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage IV grade 1 follicular lymphoma |
stage IV grade 2 follicular lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma recurrent mantle cell lymphoma |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Carmustine Cyclophosphamide Melphalan |
Cisplatin Dexamethasone Etoposide Paclitaxel Dexamethasone acetate Dexamethasone 21-phosphate BB 1101 Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013