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

Alternate Title

CI-958 in Treating Children With Recurrent Solid Tumors and Lymphomas

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 21 and under NCI CCG-0943 CCG-0943

Objectives

I.  Estimate the maximum tolerated dose of the synthetic intercalating agent 
CI-958 given as a 2-hour infusion every 3 weeks to children and adolescents 
with recurrent solid tumors and lymphomas.

II.  Assess the toxicities of CI-958 on this schedule.

III.  Assess the antitumor activity of CI-958 within the confines of a Phase I 
study.
 

Entry Criteria

Disease Characteristics:

Histologically confirmed solid tumor or lymphoma refractory to conventional
therapy and higher priority treatment

No bone marrow involvement with tumor
  Aspiration/biopsy required if high risk of metastasis, e.g., for:
     Ewing's sarcoma
     Neuroblastoma
     Rhabdomyosarcoma
     Retinoblastoma
     Peripheral neuroectodermal tumor
     Lymphoma

No brain metastases

No primary CNS tumor

Prior/Concurrent Therapy:

Recovered from prior therapy

Biologic therapy:
  Not specified

Chemotherapy:
  At least 3 weeks since chemotherapy (6 weeks since nitrosoureas)

Endocrine therapy:
  Not specified

Radiotherapy:
  No radiotherapy to more than 50% of the bone marrow
     No total-body irradiation
     No total-pelvic irradiation
  No craniospinal irradiation

Surgery:
  Not specified

Other:
  At least 3 months since bone marrow transplantation

Patient Characteristics:

Age:
  21 and under

Performance status:
  0-2

Life expectancy:
  At least 2 months

Hematopoietic:
  ANC at least 1,000
  Platelets at least 100,000 (transfusion independent)
  Hb at least 10 g/dl (transfusion allowed)

Hepatic:
  Bilirubin no greater than 1.5 x ULN
  SGOT or SGPT less than 2.5 x ULN

Renal:
  Creatinine no greater than 1.5 x ULN
  Creatinine clearance or radioisotope GFR at least 70 ml/min/1.73 sqm

Cardiovascular:
  Shortening fraction at least 27% by echocardiogram OR
  LVEF greater than 50% by echocardiogram or MUGA

Neurologic:
  No requirement for anticonvulsant therapy
  No CNS toxicity greater than grade 2

Blood/body fluid analyses to determine eligibility and imaging studies and
physical exams for tumor measurement completed within 7 days prior to
registration

Expected Enrollment

Up to 21 evaluable patients will be studied over 24 months in this multicenter 
trial.

Outline

Single-Agent Chemotherapy.  CI-958, NSC-635371 (a synthetic intercalating 
agent).

Trial Contact Information

Trial Lead Organizations

Children's Cancer Group

Carola Arndt, MD, Protocol chair		Ph: 507-284-3442 Email: carndt@mayo.edu