ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma

This study has been completed.
Study NCT00002745.   Last updated on November 26, 2008.   Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
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- Aminocamtothecin (9-AC/DMA, NSC# 603071) In Preeviously Treated Hodgin's Disease And Non-Hodgkin's Ymphoma: IWF Grades A-H
Brief Summary

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.

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.

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.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Lymphoma
Intervention  Drug: aminocamptothecin
MEDLINE PMIDs 18648813
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  110
Start Date  April 1996
Completion Date
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 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

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

Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00002745
Organization ID CDR0000064666
Secondary IDs †† CLB-9551
Study Sponsor  Cancer and Leukemia Group B
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Nancy L. Bartlett, MD     Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis    
Information Provided By National Cancer Institute (NCI)
Verification Date October 2008
First Received Date  November 1, 1999
Last Updated Date November 26, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers