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| Sponsors and Collaborators: |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003207 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Combining PSC 833 with a chemotherapy drug may reduce resistance to the drug and allow more tumor cells to be killed.
PURPOSE: Phase I trial to study the effectiveness of liposomal doxorubicin and PSC 833 in treating patients who have AIDS-related Kaposi's sarcoma or other advanced cancers.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma Unspecified Adult Solid Tumor, Protocol Specific |
Drug: pegylated liposomal doxorubicin hydrochloride Drug: valspodar |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Study on Doxil and SDZ PSC 833 in the Treatment of AIDS-Associated Kaposi's Sarcoma |
| Study Start Date: | February 1998 |
OBJECTIVES: I. Evaluate the safety profile and tolerability of doxorubicin HCl liposome (Doxil) and PSC 833 in patients with AIDS-related Kaposi's sarcoma and other advanced malignancies. II. Determine the maximum tolerated dose of Doxil when administered with PSC 833 in this patient population.
III. Determine the dose-limiting toxicity of Doxil when administered with PSC 833 in this patient population. IV. Determine the effects of PSC 833 on Doxil pharmacokinetics.
OUTLINE: This is a dose-escalation study of doxorubicin HCl liposome (Doxil). Patients receive Doxil IV over 1 hour on day 1 of each course. During the second and subsequent courses, patients also receive a loading dose of PSC 833 IV over 2 hours and a maintenance dose of PSC 833 IV over 72 hours beginning 15 minutes after completion of Doxil infusion. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
The first seven cohorts of patients receive standard-dose Doxil. The eighth and ninth cohorts of 3-6 patients each receive escalating doses of Doxil until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 12-18 patients will be accrued for this study within 12-18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven Kaposi's sarcoma with 10 or more mucocutaneous lesions or a visceral lesion with at least 2 assessable cutaneous lesions OR Histologically confirmed advanced malignancy that is refractory to standard treatment or for which no standard therapy exists
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: More than 4 months Hematopoietic: Neutrophil count at least 1,000/mm3 Platelet count at least 75,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin less than 1.5 times normal SGOT no greater than 2 times normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No clinically significant congestive heart failure Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active opportunistic infections requiring antibiotic treatment No moderate to severe sensory and motor peripheral neuropathy No other prior or concurrent malignancy except carcinoma in situ of the cervix or nonmelanoma skin cancer No hypersensitivity to doxorubicin HCl liposome or cyclosporine
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior interferon Chemotherapy: At least 4 weeks since prior cytotoxic chemotherapy Prior doxorubicin HCl liposome allowed No other concurrent cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy or external beam therapy No concurrent palliative radiotherapy Surgery: Not specified Other: No concurrent medications known to interact with cyclosporine
Contacts and Locations| United States, Missouri | |
| Washington University Barnard Cancer Center | |
| Saint Louis, Missouri, United States, 63110 | |
| Study Chair: | Paula M. Fracasso, MD, PhD | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
More Information
| Study ID Numbers: | CDR0000066062, WU-106, NCI-T97-0073 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003207 History of Changes |
| Health Authority: | United States: Federal Government |
|
unspecified adult solid tumor, protocol specific AIDS-related Kaposi sarcoma recurrent Kaposi sarcoma |
|
Virus Diseases Anti-Bacterial Agents Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Malignant Mesenchymal Tumor Sarcoma, Kaposi |
Sarcoma DNA Virus Infections Doxorubicin Recurrence Kaposi Sarcoma Herpesviridae Infections |
|
Neoplasms by Histologic Type Antineoplastic Agents Sarcoma, Kaposi Antibiotics, Antineoplastic Pharmacologic Actions Doxorubicin Herpesviridae Infections |
Virus Diseases Neoplasms, Connective and Soft Tissue Neoplasms Therapeutic Uses Sarcoma Neoplasms, Vascular Tissue DNA Virus Infections |
