- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002745
Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma
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 Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20307-5000
- Walter Reed Army Medical Center
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Cancer Center
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University Barnard Cancer Center
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New Jersey
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Camden, New Jersey, United States, 08103
- Cooper Cancer Institute
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Paterson, New Jersey, United States, 07503
- St. Joseph's Hospital and Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: aminocamptothecin
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response
Time Frame: 2 years post treatment
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2 years post treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Toxicity
Time Frame: day 1 of each cycle
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day 1 of each cycle
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9-AC/DMA concentrations
Time Frame: Pre-treatment cycle 1 and just prior to completion of cycle 1
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Pre-treatment cycle 1 and just prior to completion of cycle 1
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Nancy L. Bartlett, MD, Washington University Siteman Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2012-02791
- U10CA031946 (U.S. NIH Grant/Contract)
- CLB-9551
- CDR0000064666 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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