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CompletedNCT00002745Updated Feb 11, 2013

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

A Phase 2 interventional study of aminocamptothecin in Lymphoma, sponsored by National Cancer Institute (NCI). Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-11.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lymphoma

Keywords

  • Waldenstrom macroglobulinemia
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent small lymphocytic lymphoma
03

In context

Lymphoma

5,623 studies on the registry are indexed under Lymphoma; 823 are open to participants now.

This study's enrollment of 37 is close to the median of 40 across 4,534 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,554 studies on the registry; 334 are open to participants now.

Of its 407 completed or terminated interventional studies of FDA-regulated products, 370 (91%) have results posted.

Browse National Cancer Institute (NCI) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    aminocamptothecin

    aminocamptothecin

    Drug: aminocamptothecin

Interventions

  • Drugaminocamptothecin

    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

06

What researchers measure

Primary outcomes

  1. Response

    Time frame: 2 years post treatment

Secondary outcomes

  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

07

Study locations

5 sites
  • Walter Reed Army Medical Center
    Washington D.C., District of Columbia 20307-5000, United States
  • University of Minnesota Cancer Center
    Minneapolis, Minnesota 55455, United States
  • Washington University Barnard Cancer Center
    St Louis, Missouri 63110, United States
  • Cooper Cancer Institute
    Camden, New Jersey 08103, United States
  • St. Joseph's Hospital and Medical Center
    Paterson, New Jersey 07503, United States
08

References and documents

Publications

  • 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. PubMed 18648813 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 1996, a primary completion of Apr 2003 and a completion of Jan 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 1999
First posted
Apr 22, 2004
Start
Apr 1996
Primary completionActual
Apr 2003
CompletionActual
Jan 2008
Last update
Feb 11, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00002745
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 22, 2004
Start date
Apr 1996
Primary completion
Apr 2003
Completion
Jan 2008
Last update
Feb 11, 2013

Study contacts

Nancy L. Bartlett, MD
study chair · Washington University Siteman Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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