Non Hodgkin Lymphoma Clinical Trial

Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin’s Disease or Non-Hodgkin’s Lymphoma

Summary

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. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

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Full Description

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.

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.

View Eligibility Criteria

Eligibility 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.

PATIENT CHARACTERISTICS:

Age: 18 and over
Performance status: CALGB 0-2

Unless hypersplenism or biopsy-proven bone marrow involvement:

Absolute granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3
Bilirubin normal
AST no greater than 4 times normal
Creatinine normal
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

PRIOR CONCURRENT THERAPY:

No prior allogeneic or autologous bone marrow transplant
More than 3 weeks since chemotherapy (6 weeks since nitrosoureas, melphalan, or mitomycin)
No prior camptothecin
More than 3 weeks since radiotherapy

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

37

Study ID:

NCT00002745

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There are 5 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

37

Study ID:

NCT00002745

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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