Phase II Study of Multimodality Therapy in Mantle Cell Lymphoma
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Northwestern University
- Locations
- 1
Study Overview
Brief Summary
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 or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation and/or biological therapy in treating patients who have stage III, stage IV, or recurrent mantle cell lymphoma.
Detailed Description
OBJECTIVES:
- Determine the toxicities of combination chemotherapy followed by allogeneic or autologous bone marrow transplantation or peripheral blood stem cell transplantation and/or interferon and interleukin therapy in patients with refractory or stage III or IV mantle cell lymphoma.
- Determine the complete response rate in these patients after these treatments.
- Evaluate the prognostic factors in this patient population.
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy consisting of cyclophosphamide IV, doxorubicin IV, and teniposide IV over 2 hours on day 1, oral prednisone on days 1-5, vincristine IV and methotrexate IV over 2 hours on day 21, cytarabine IV over 2 hours every 12 hours for a total of 2 doses on day 22, and oral leucovorin calcium every 6 hours beginning on day 22 and continuing until methotrexate levels recover. Treatment repeats every 42 days for 2 courses. Patients achieving complete response or partial response receive an additional course of induction therapy. Patients achieving maximal response following 2 courses of induction chemotherapy undergo transplantation.
Patients under 50 years with an HLA matched donor undergo allogeneic bone marrow transplantation (BMT). Patients receive busulfan IV every 6 hours for a total of 14 doses beginning on day -8 and continuing for 3.5 days. At 24 hours following the last dose of busulfan, patients receive cyclophosphamide IV over 2 hours daily for 2 days. Patients receive allogeneic bone marrow infusion on day 0.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage III, IV, or recurrent mantle cell lymphoma
- •CD5 positive OR
- •Evidence of bcl-1 oncogene overexpression
- •Measurable or evaluable disease with at least one of the following:
- •Clear cut radiographic findings
- •Clearly defined bidimensional defect or mass at least 2 cm in diameter on radionuclide or CT scan
- •Enlarged spleen extending at least 2 cm below costal margin with lymphomatous involvement only
- •Enlarged liver with proof of lymphoma by biopsy
- •CNS involvement allowed
- •Fully HLA matched donor for allogeneic transplantation
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Bilirubin no greater than 3.0 mg/dL
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No significant cardiac disease
- •No other prior malignancies except previously treated nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No other medical problems that would preclude study
- •HIV negative
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •Chemotherapy:
- •See Disease Characteristics
- •Prior chemotherapy, including doxorubicin, allowed
- •Endocrine therapy:
- •See Disease Characteristics
- •Prior steroids allowed
- •Radiotherapy:
- •See Disease Characteristics
- •Prior radiotherapy allowed excluding the indicator lesions
- •Not specified
Exclusion Criteria
- Not provided