Status:
COMPLETED
Phase I and Pharmacology Study of Camptothecin-20-O-Propionate Hydrate (CZ48) in Patients With Solid Tumors or Lymphoma
Lead Sponsor:
New Mexico Cancer Research Alliance
Collaborating Sponsors:
Christus Stehlin Foundation for Cancer Research
Conditions:
Advanced Solid Tumors
Lymphomas
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a phase I and pharmacology study of Camptothecin-20-O-Propionate Hydrate (CZ48) in Patients with Solid Tumors or Lymphoma. OBJECTIVES Primary: 1. To describe the dose limiting toxicities an...
Detailed Description
CZ48 is an analog of the topoisomerase I inhibitor Camptothecin (CPT). CPT is an alkaloid extracted from the Chinese tree, Camptotheca acuminata. Only the S isomer (the natural form) is biologically a...
Eligibility Criteria
Inclusion
- All patients, 18 years of age or older, with incurable advanced solid tumors or lymphomas are eligible.
- Patients must have a Zubrod performance status of 0-1.
- Patients must sign an informed consent document.
- Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of \> 1,500 or cells/mm3 and platelet count \>100,000/mm3 -along with an absence of a red blood cell transfusion in the two weeks prior to their participation in the trial.
- Patients should have adequate hepatic function with a total bilirubin within normal range and SGOT or SGPT \< two times the upper limit of normal, and adequate renal function as defined by a serum creatinine within the upper limit of normal.
- Patients may receive no other concurrent anticancer treatments such as chemotherapy, hormonotherapy (except for prostate cancer patients on LHRH agonists), immunotherapy, biological agents, investigational agents, or radiation therapy during this trial, and should be off these treatments for at least 2 weeks, or until they have completely recovered from the side effects of these treatments, whichever is longest, except for persistent grade 1 neuropathy in patients who received prior platinum or taxanes.
Exclusion
- Patients with symptomatic brain metastases are excluded from this study.
- Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception (contraceptive pill, or IUD, or two mechanical barriers).
- Patients with severe uncontrolled medical problems are not eligible for this trial.
- Patients who have too much esterase activity in the blood, with a conversion rate yielding concentration of CPT \> 20 ng/ml in vitro. Please see section 6.5 for sample collection, preparation and shipping. A validated analysis will be performed according to Sponsor SOP SFCR.PH.R.01.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00947739
Start Date
September 1 2008
End Date
March 1 2014
Last Update
June 18 2015
Active Locations (2)
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1
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131
2
University of Texas Health Sciences Center
San Antonio, Texas, United States, 78229