Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	NCI-94-C-0065C NCI-MB-322, NCI-T93-0122N, T93-0122

Objectives

I.  Estimate the response rate to aminocamptothecin (9-AC) administered by 
72-hour infusion to adults with recurrent or persistent Hodgkin's disease or 
non-Hodgkin's lymphoma.

II.  Evaluate tumor levels of topoisomerase I and mdr-1 before and after 
therapy with 9-AC, and correlate these levels with response.

III.  Assess the effect of treatment with 9-AC on tumor mdr-1 and 
topoisomerase I levels.

Entry Criteria

Disease Characteristics:

Relapsed Hodgkin's disease or non-Hodgkin's lymphoma of any
stage
  Pathology review and confirmation required at Hematopathology
  Section, Laboratory of Pathology, NCI

Recurrent or persistent disease following standard therapy
(i.e., a doxorubicin/vincristine-containing regimen such as
EPOCH) that requires systemic therapy

Measurable disease required

Prior/Concurrent Therapy:

Not specified

Patient Characteristics:

Age:
  18 and over

Performance status:
  Karnofsky 60-100%

Hematopoietic:
  (in the absence of bone marrow involvement with tumor)
  AGC greater than 1,000
  Platelets at least 100,000

Hepatic:
  (in the absence of liver involvement with tumor)
  Bilirubin no greater than 2 x normal
  SGOT no greater than 2 x normal

Renal:
  (in the absence of kidney involvement with tumor)
  Creatinine no greater than 1.5 mg/dl OR
  Creatinine clearance at least 50 ml/min

Other:
  No poor medical or psychiatric risks due to nonmalignant
     systemic disease
  HIV seronegative
  No pregnant or nursing women
  Effective contraception required of fertile patients

Expected Enrollment

Up to 30 patients in each stratum (Hodgkin's or non-Hodgkin's) will be 
accrued; if no response is seen in the first 14 patients within a stratum, 
accrual to that stratum will close.  The study is expected to be completed 
within 1 year.

Outline

Nonrandomized study.  In each stratum, the first 15 evaluable patients entered 
are treated on Regimen A and the next 15, on Regimen B.

Regimen A:  Single-Agent Chemotherapy.  Aminocamptothecin, 9-AC, NSC-603071.

Regimen B:  Single-Agent Chemotherapy with Hematologic Toxicity Attenuation.  
9-AC; with Granulocyte Colony Stimulating Factor (Amgen), G-CSF, NSC-614629.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Wyndham Wilson, MD, PhD, Protocol chair		Ph: 301-435-2415