RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients who have refractory or recurrent Hodgkin's disease or non-Hodgkin's lymphoma.

Condition	Treatment or Intervention	Phase
recurrent diffuse small lymphocytic/marginal zone lymphoma Waldenstrom's Macroglobulinemia recurrent grade I follicular small cleaved cell lymphoma recurrent grade II follicular mixed cell lymphoma	Drug: aminocamptothecin	Phase II

Further Study Details: 

OBJECTIVES: I. Evaluate the response rate and duration of response to aminocamptothecin (9-AC) in patients with refractory or relapsed Hodgkin's disease or non-Hodgkin's lymphoma. II. Assess the toxicity of 9-AC in these patients. III. Validate a preliminary pharmacodynamic model relating total 9-AC concentration, albumin, and bilirubin to toxicity. IV. Determine whether 9-AC concentrations correlate with response.

PROTOCOL OUTLINE: Patients are stratified by disease histology (International Working Formulation (IWF) A-C vs IWF D-F) and center. Patients receive aminocamptothecin IV continuously on days 1-3. Treatment repeats every 2 weeks for a minimum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease, partial response (PR), or complete response (CR) may receive 2 additional courses past best response (minimum of 6 courses if PR or CR). Patients are followed every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A minimum of 110 eligible patients (40 with low grade non-Hodgkin's lymphoma (NHL), 35 with intermediate grade NHL, and 35 with Hodgkin's disease) will be accrued over 2.5 years. Accrual of patients with intermediate grade NHL and Hodgkin's disease closed effective 04/15/2000.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically documented Hodgkin's disease (closed to accrual 4/15/2000) OR Histologically documented non-Hodgkin's lymphoma (NHL) of one of the following International Working Formulation (IWF) histologies: Small lymphocytic (absolute lymphocyte count less than 5,000): IWF A Follicular, predominantly small cleaved cell: IWF B Follicular mixed: IWF C Follicular large cell: IWF D* Diffuse small cleaved cell: IWF E* Diffuse mixed: IWF F* Diffuse large cell: IWF G* Large cell, immunoblastic: IWF H* * Accrual of patients with these diagnoses closed 4/15/2000
• Pathology review required within 60 days of registration
• Refractory to or relapsed after prior chemotherapy as follows: Low-grade NHL (IWF A-C): 1 or 2 prior therapies; Intermediate-grade NHL (IWF D-H): 1 prior therapy (stratum closed 4/15/2000) Hodgkin's disease: 1 or 2 prior therapies (stratum closed 4/15/2000)
• Treatment with the same drugs on 2 different schedules considered 1 therapy
• Measurable disease by physical exam or imaging studies; Mass larger than 1 x 1 cm; Documented progression required of previously irradiated lesions The following are not considered measurable: Ascites or pleural effusion; Bone marrow involvement; Positive barium studies; Bony disease (lytic lesions noted)
• No mantle cell or transformed lymphoma
• No parenchymal or leptomeningeal 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: No prior allogeneic or autologous bone marrow transplant
• Chemotherapy: See Disease Characteristics; More than 3 weeks since chemotherapy (6 weeks since nitrosoureas, melphalan, or mitomycin); No prior camptothecin
• Endocrine therapy: Not specified
• Radiotherapy: More than 3 weeks since radiotherapy
• Surgery: Not specified

--Patient Characteristics--

• Age: 18 and over
• Performance status: CALGB 0-2
• Hematopoietic: (Unless hypersplenism or biopsy-proven bone marrow involvement) Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin normal; AST no greater than 4 times normal
• Renal: Creatinine normal
• Other: No suspected HIV infection; No second malignancy within past 5 years except: Curatively treated carcinoma of the cervix; Curatively treated basal cell skin cancer; No uncontrolled infection or other serious medical condition; No psychiatric condition that precludes informed consent; Not pregnant or nursing; Fertile patients must use effective contraception

District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States
Minnesota
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States
Missouri
      Washington University Barnard Cancer Center, Saint Louis,  Missouri,  63110,  United States
New Jersey
      Cooper Cancer Institute, Camden,  New Jersey,  08103,  United States
      St. Joseph's Hospital and Medical Center, Paterson,  New Jersey,  07503,  United States

Study chairs or principal investigators

Nancy Bartlett,  Study Chair,  Cancer and Leukemia Group B   

Study ID Numbers:  CDR0000064666; CLB-9551
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002745
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08