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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002745
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: aminocamptothecin
Phase II

MedlinePlus related topics:   Cancer    Hodgkin's Disease    Lymphoma   

Drug Information available for:   9-Amino-20-camptothecin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   110
Study Start Date:   April 1996

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002745

Locations
United States, District of Columbia
Walter Reed Army Medical Center    
      Washington, District of Columbia, United States, 20307-5000
United States, Minnesota
University of Minnesota Cancer Center    
      Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University Barnard Cancer Center    
      Saint Louis, Missouri, United States, 63110
United States, New Jersey
Cooper Cancer Institute    
      Camden, New Jersey, United States, 08103
St. Joseph's Hospital and Medical Center    
      Paterson, New Jersey, United States, 07503

Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)

Investigators
Study Chair:     Nancy L. Bartlett, MD     Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000064666, CLB-9551
First Received:   November 1, 1999
Last Updated:   August 12, 2008
ClinicalTrials.gov Identifier:   NCT00002745
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
Waldenstrom macroglobulinemia  
recurrent grade 1 follicular lymphoma  
recurrent grade 2 follicular lymphoma  
recurrent small lymphocytic lymphoma  

Study placed in the following topic categories:
Immunoproliferative Disorders
Hodgkin's disease
Leukemia, B-cell, chronic
Hodgkin lymphoma, adult
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Recurrence
Lymphatic Diseases
Waldenstrom Macroglobulinemia
Waldenstrom macroglobulinemia
9-amino-20-camptothecin
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease
Follicular lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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