RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of T138067 sodium in treating patients with advanced refractory cancer.

Condition	Treatment or Intervention	Phase
Leukemia Lymphoma Multiple Myeloma	Drug: T138067 sodium	Phase I

Further Study Details: 

OBJECTIVES: I. Determine the maximum tolerated dose of T138067 sodium that can be given to patients with advanced refractory cancer on a 28-day schedule and establish a dose for further study.

II. Evaluate the safety and dose limiting toxicity of T138067 sodium in these patients.

III. Determine the pharmacokinetic parameters after a single intravenous dose of this agent in these patients.

IV. Obtain safety data and preliminary efficacy information after repetition of single doses of T138067 sodium in these patients.

PROTOCOL OUTLINE: This is an open label, dose escalation study.

Patients receive T138067 sodium by IV over 3 hours. Patients may be retreated every 4 weeks for up to 6 courses (6 months total) in the absence of disease progression or dose limiting toxicity (DLT).

At least 3 patients are treated at each dose level in the absence of DLT. The maximum tolerated dose is defined as the dose level where 2 of 3-6 patients experience DLT.

PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued into this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed advanced refractory cancer
• Must meet one of the following criteria: Failed at least 1 regimen of radiotherapy, chemotherapy, or immunotherapy and not a candidate for a regimen of higher efficacy; Refractory to existing standard therapy and not candidate for a regimen of higher efficacy; Advanced malignancy for which there is no standard chemotherapy available
• No known brain metastases or leptomeningeal involvement

--Prior/Concurrent Therapy--

• Biologic therapy: See Disease Characteristics; At least 4 weeks since prior immunotherapy; No concurrent immunotherapy or biologic response modifier therapy
• Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy; No concurrent chemotherapy
• Endocrine therapy: No concurrent corticosteroids
• Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiotherapy; No concurrent radiotherapy
• Surgery: At least 3 weeks since any prior major surgery
• Other: No organ allograft; At least 30 days since any prior investigational agents; No concurrent nonsteroidal antiinflammatory agents or aspirin; No concurrent alternative therapies (i.e., herbal medicines, high doses of vitamins); No other concurrent investigational agents

--Patient Characteristics--

• Age: 18 and over
• Performance status: Karnofsky 60-100%
• Life expectancy: Greater than 3 months
• Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Prothrombin time at least 30% of control; Partial thromboplastin time at least 30% of control
• Hepatic: Bilirubin less than 2 mg/dL; ALT and AST no greater than 2 times normal; Alkaline phosphatase no greater than 2 times normal
• Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min
• Cardiovascular: No New York Heart Association class III or IV heart disease; No myocardial infarction in the past 6 months
• Other: No immunodeficiency syndrome (acquired or congenital); No uncontrolled infection; No significant comorbidity that may compromise participation in this study; Not pregnant; Effective contraception required of all fertile patients during and until 3 months after study

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

David R. Spriggs,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000066341; MSKCC-98004; NCI-G98-1443; TULA-T9801
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003359
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08