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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aminocamptothecin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Waldenstrom macroglobulinemia, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent small lymphocytic lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Walter Reed Army Medical Center
  • University of Minnesota Cancer Center
  • Washington University Barnard Cancer Center
  • Cooper Cancer Institute
  • St. Joseph's Hospital and Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

aminocamptothecin

Arm Description

aminocamptothecin

Outcomes

Primary Outcome Measures

Response

Secondary Outcome Measures

Toxicity
9-AC/DMA concentrations

Full Information

First Posted
November 1, 1999
Last Updated
February 8, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002745
Brief Title
Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma
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 Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 1996 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Waldenstrom macroglobulinemia, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent small lymphocytic lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aminocamptothecin
Arm Type
Experimental
Arm Description
aminocamptothecin
Intervention Type
Drug
Intervention Name(s)
aminocamptothecin
Intervention Description
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
Primary Outcome Measure Information:
Title
Response
Time Frame
2 years post treatment
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
day 1 of each cycle
Title
9-AC/DMA concentrations
Time Frame
Pre-treatment cycle 1 and just prior to completion of cycle 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy L. Bartlett, MD
Organizational Affiliation
Washington University Siteman Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5000
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University Barnard Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cooper Cancer Institute
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18648813
Citation
Bartlett NL, Johnson JL, Wagner-Johnston N, Ratain MJ, Peterson BA; Cancer and Leukemia Group B. Phase II study of 9-aminocamptothecin in previously treated lymphomas: results of Cancer and Leukemia Group B 9551. Cancer Chemother Pharmacol. 2009 Apr;63(5):793-8. doi: 10.1007/s00280-008-0803-x. Epub 2008 Jul 23.
Results Reference
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Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma

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