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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00002745

Collaborator

(none)

Enrollment

Locations

Arm

141

Duration (Months)

7.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: aminocamptothecin	Phase 2

Detailed Description

OBJECTIVES:

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.
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.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

PHASE II STUDY OF 9-AMINOCAMPTOTHECIN (9-AC/DMA, NSC# 603071) IN PREVIOUSLY TREATED HODGKIN'S DISEASE AND NON-HODGKIN'S LYMPHOMA: IWF GRADES A-H

Study Start Date :

Apr 1, 1996

Actual Primary Completion Date :

Apr 1, 2003

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: aminocamptothecin aminocamptothecin	Drug: aminocamptothecin 850 micrograms/square meter/day (total dose 2550 micrograms/square meter) via central venous catheter using infusion pump over 72 hours + one cycle Cycle repeated every 14 days for minimum of 6 cycles if partial or complete response

Arm

Intervention/Treatment

Experimental: aminocamptothecin

aminocamptothecin

Drug: aminocamptothecin

850 micrograms/square meter/day (total dose 2550 micrograms/square meter) via central venous catheter using infusion pump over 72 hours + one cycle Cycle repeated every 14 days for minimum of 6 cycles if partial or complete response

Outcome Measures

Primary Outcome Measures

Response [2 years post treatment]

Secondary Outcome Measures

Toxicity [day 1 of each cycle]
9-AC/DMA concentrations [Pre-treatment cycle 1 and just prior to completion of cycle 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5000
2	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
3	Washington University Barnard Cancer Center	Saint Louis	Missouri	United States	63110
4	Cooper Cancer Institute	Camden	New Jersey	United States	08103
5	St. Joseph's Hospital and Medical Center	Paterson	New Jersey	United States	07503