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Liposomal Doxorubicin and PSC 833 in Treating Patients With AIDS-Related Kaposi's Sarcoma or Other Advanced Cancers
This study has been completed.
Study NCT00003207   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes

November 1, 1999
July 23, 2008
February 1998
 
 
 
Complete list of historical versions of study NCT00003207 on ClinicalTrials.gov Archive Site
 
 
 
Liposomal Doxorubicin and PSC 833 in Treating Patients With AIDS-Related Kaposi's Sarcoma or Other Advanced Cancers
Phase I Study on Doxil and SDZ PSC 833 in the Treatment of AIDS-Associated Kaposi's Sarcoma

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.

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.

Phase I
Interventional
Treatment
  • Sarcoma
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: pegylated liposomal doxorubicin hydrochloride
  • Drug: valspodar
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003207
 
CDR0000066062, WU-106, NCI-T97-0073
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
National Cancer Institute (NCI)
Study Chair: Paula M. Fracasso, MD, PhD Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
National Cancer Institute (NCI)
September 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP