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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


Phase 2
18 Years
70 Years
Not Enrolling
Both
Leukemia, Lymphoma

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Trial Information

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


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.

Inclusion 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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Barry R. Meisenberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066407

NCT ID:

NCT00003402

Start Date:

January 1999

Completion Date:

December 2002

Related Keywords:

  • Leukemia
  • Lymphoma
  • 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
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201