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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 17 to physiologic 69 NCI LAC-USC-0C862 NCI-T84-0429D, T84-0429

Objectives

I.  Determine the maximum tolerated dose of TMCA when administered orally for 
5 days every 3-4 weeks in patients with proven therapy-resistant solid tumors 
and lymphomas.
II.  Determine, if possible, the efficacy of TMCA administered in this manner.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients over the age of 17 years but 
less than a physiologic age of 70 years with solid tumor or lymphoma 
demonstrated to be refractory or resistant to conventional methods of therapy. 
 Those with solid tumors must have histologic proof of malignancy.  Patients 
must have recovered from the effects of all prior chemotherapy, immunotherapy, 
or radiotherapy, have an estimated life expectancy of at least 8 weeks, and 
have a Karnofsky performance status of greater than 50%.  Adequate 
hematopoietic, renal, and hepatic function are required; those with bone 
marrow involvement, prior therapy with nitrosoureas or mitomycin-C, or 
extensive prior radiotherapy (to more than 25% of the bone marrow) may be 
treated at a given dose provided the dose has been proven safe in at least 3 
patients without bone marrow involvement.  There may be no gross alterations 
in other biochemical parameters (blood glucose, serum electrolytes, calcium, 
phosphorus) that might obscure the effect of the drug and no gastrointestinal 
disturbances that could interfere with drug absorption.  Patients with signs 
suggestive of CNS involvement are ineligible.  There may be no signs or 
symptoms of concurrent acute infection; pregnancy excludes, and women of 
reproductive age must be using an effective means of contraception.

Expected Enrollment

At least 3 patients will be evaluated at each nontoxic or subtoxic dose level; 
at least 5 will be treated at levels that produce acceptable and reversible 
toxicity.  As of April 1990, the MTD has been reached, and the study remains 
open to complete pharmacologic studies.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  Trimethylcolchicinic acid methyl ether D-tartrate, 
TMCA, NSC-36354.

Ko RJ, Li WY, Koda RT: Determination of the antimitotic agents N-desacetylcolchicine, demecolcine and colchicine in serum and urine. J Chromatogr 525 (2): 411-8, 1990.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

USC/Norris Comprehensive Cancer Center and Hospital

Franco Muggia, MD, Protocol chair		Ph: 212-263-6485 Email: muggif01@gcrc.med.nyu.edu