Phase I and Pharmacology Study of Camptothecin-20-O-Propionate Hydrate (CZ48) in Patients With Solid Tumors or Lymphoma

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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 and adverse event profile of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day.

2. To determine Phase II recommended dose of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day.

Secondary:

3. To perform a pharmacokinetic study of orally administered CZ48 in the plasma.

4. To assess responses by RECIST criteria.

5. To follow patients for survival.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New Mexico Cancer Care Alliance
• Collaborator: Christus Stehlin Foundation for Cancer Research
• Treatments: Camptothecin

Criteria

Inclusion Criteria:

1. All patients, 18 years of age or older, with incurable advanced solid tumors or lymphomas are eligible.

2. Patients must have a Zubrod performance status of 0-1.

3. Patients must sign an informed consent document.

4. 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.

5. 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.

6. 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 Criteria:

1. Patients with symptomatic brain metastases are excluded from this study.

2. 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).

3. Patients with severe uncontrolled medical problems are not eligible for this trial.

4. 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.