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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002745
Recruitment Status : Completed
First Posted : April 22, 2004
Last Update Posted : February 11, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

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:


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 : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 1996
Actual Primary Completion Date : April 2003
Actual Study Completion Date : January 2008

Arm Intervention/treatment
Experimental: 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

Primary Outcome Measures :
  1. Response [ Time Frame: 2 years post treatment ]

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: day 1 of each cycle ]
  2. 9-AC/DMA concentrations [ Time Frame: Pre-treatment cycle 1 and just prior to completion of cycle 1 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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.


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002745

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
National Cancer Institute (NCI)
Study Chair: Nancy L. Bartlett, MD Washington University Siteman Cancer Center

Publications of Results:
Responsible Party: National Cancer Institute (NCI) Identifier: NCT00002745     History of Changes
Other Study ID Numbers: NCI-2012-02791
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000064666 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: April 22, 2004    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: January 2013

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

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases