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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response

Outcome Time Frame:

2 years post treatment

Safety Issue:

No

Principal Investigator

Nancy L. Bartlett, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02791

NCT ID:

NCT00002745

Start Date:

April 1996

Completion Date:

January 2008

Related Keywords:

  • Lymphoma
  • Waldenstrom macroglobulinemia
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent small lymphocytic lymphoma
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503
Cooper Cancer InstituteCamden, New Jersey  08103
Washington University Barnard Cancer CenterSaint Louis, Missouri  63110