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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed over 18 NCI JHOC-T93-0186 NCI-T93-0186D, T93-0186

Objectives

I.  Determine the maximum tolerated dose (MTD) of CI-980 given as a 72-hour 
infusion every 21 days, with and without granulocyte colony stimulating factor 
(G-CSF).

II.  Describe and quantitate the toxicities of CI-980 and of CI-980/G-CSF 
administered on these schedules.

III.  Study the clinical pharmacology of CI-980 on this schedule and search 
for correlations between pharmacologic parameters and clinical endpoints.

IV.  Search for preliminary evidence of therapeutic activity of CI-980 in 
patients with advanced cancer.

Entry Criteria

Disease Characteristics:

Histologically or cytologically documented diagnosis of cancer
(solid tumor or lymphoma) that is refractory to conventional
therapy modalities or for which no conventional treatment
exists

No bone marrow involvement
  Bone marrow aspiration/biopsy required in patients with
  widespread bone metastases

  Bilateral marrow aspiration/biopsy required of lymphoma
  patients

No primary CNS neoplasms

Prior/Concurrent Therapy:

Biologic therapy:
  No concurrent immunotherapy

Chemotherapy:
  (Modifications may be allowed with the consensus of the
     principal investigators)
  No more than 1 prior chemotherapy regimen using alkylating
     and/or myelosuppressive agents (except low-dose cisplatin)
  No more than 4 prior courses of carboplatin
  No more than 2 courses of either mitomycin or a nitrosourea
  No concurrent chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior radiotherapy to wide ports involving the pelvis or
     more than 25% of bone marrow
  No concurrent radiotherapy

Surgery:
  At least 14 days since major surgery

Patient Characteristics:

Age:
  Over 18

Performance status:
  ECOG 0-2

Life expectancy:
  At least 6 weeks

Hematopoietic:
  WBC greater than 4,000
  Platelets greater than 100,000

Hepatic:
  Bilirubin no more than 1.5 mg/dl

Renal:
  Creatinine no more than 1.5 mg/dl

Cardiovascular:
  No uncontrollable moderate to severe hypertension, i.e.:
     No systolic pressure greater than 170 mm Hg
     No diastolic pressure greater than 100 mm Hg

Other:
  No active infection
  No medical problems that limit full compliance with the study
     or expose the patient to undue risk
  No active psychosis or other CNS disorder that would preclude
     observation, identification, or reporting of CNS toxicity
  No pregnant women
  Adequate contraception required of fertile patients

Expected Enrollment

At least 3 patients will be entered at each dose studied.

Outline

Single-Agent Chemotherapy with and without Hematopoietic Stimulation.  CI-980, 
NSC-635370; with and without Granulocyte Colony Stimulating Factor (Amgen), 
G-CSF, NSC-614629.

Rowinsky EK, Noe DA, Grochow LB, et al.: Phase I and pharmacological study of CI-980, a synthetic and structurally unique antimicrotubule agent, on a 72-hour continuous infusion schedule in adults with solid tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-1477, 459, 1995.

Trial Contact Information

Trial Lead Organizations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eric Rowinsky, MD, Protocol chair		Ph: 210-616-5945; 800-340-2872 Email: erowinsk@idd.org