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

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Drug: aminocamptothecin

Study type: Interventional

Funder types: NIH

Identifiers

NCT00002745

CLB-9551

CDR0000064666 (Registry Identifier)

U10CA031946 (U.S. NIH Grant/Contract)

NCI-2012-02791

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

aminocamptothecin

Experimental group

Description:

aminocamptothecin

Treatment:

Drug: aminocamptothecin