Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of combining UCN-01 with fludarabine in treating patients who have relapsed or refractory chronic lymphocytic leukemia or lymphocytic lymphoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: National Cancer Institute (NCI)
• Treatments: 7-hydroxystaurosporine; Fludarabine; Fludarabine phosphate; Staurosporine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed chronic lymphocytic leukemia (CLL) or B-cell small lymphocytic lymphoma (SLL)

• CLL is defined as:

• Persistent lymphocytosis greater than 5,000/mm^3

• CD19/CD5/CD23 positive

• Kappa or lambda light chain restriction

• Refractory to or disease progression after 1 or 2 prior treatment regimens

• Retreatment with oral chlorambucil is allowed and considered a second regimen

• At least one of the chlorambucil treatments must be for 3 months or longer

• At least 4 courses of cyclophosphamide, vincristine, and prednisone with or without doxorubicin allowed

• Patients may have received prior fludarabine as first- or second-line therapy if there is evidence of at least partial response and time to progression after initial fludarabine therapy was at least 12 months

• No CNS involvement by lymphoma

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2 OR

• Karnofsky 60-100%

Life expectancy

• More than 3 months

Hematopoietic

• See Disease Characteristics

• Absolute neutrophil count at least 1,000/mm^3

• Platelet count at least 100,000/mm^3

• No autoimmune hemolytic anemia or thrombocytopenia secondary to CLL or SLL requiring ongoing therapy with prednisone or other immunosuppressive agents

Hepatic

• Bilirubin normal

• AST and ALT no greater than 2.5 times upper limit of normal

Renal

• Creatinine normal OR

• Creatinine clearance at least 60 mL/min

Cardiovascular

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

Pulmonary

• DLCO greater than 60% predicted

• FEV_1 greater than 70% predicted

• No significant underlying pulmonary disease

Other

• No other malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix

• No insulin-dependent diabetes mellitus

• No other uncontrolled concurrent illness

• No ongoing or active infection

• No pre-existing peripheral neuropathy grade 2 or greater

• No psychiatric illness or social situation that would preclude study compliance

• No prior allergic reactions to compounds of similar chemical or biological composition to UCN-01 or other agents in this study

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

• At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy

• See Hematopoietic

Radiotherapy

• No prior mediastinal radiation

• At least 4 weeks since prior radiotherapy and recovered

Surgery

• Not specified

Other

• No other concurrent investigational agents

• No concurrent combination antiretroviral therapy for HIV-positive patients