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Phase I Study on Doxil and SDZ PSC 833 in the Treatment of AIDS-Associated Kaposi's Sarcoma and Other Advanced Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Sarcoma, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study on Doxil and SDZ PSC 833 in the Treatment of AIDS-Associated Kaposi's Sarcoma and Other Advanced Malignancies

Inclusion Criteria


INCLUSION CRITERIA

- Histologically documented malignancy refractory to standard treatment or for which no
standard treatment exists, or biopsy proven Kaposi's sarcoma with mucocutaneous
lesions numbering 10 or more or a documented visceral KS lesion with at least 2
assessable cutaneous lesions.

- A life expectancy of >4 months.

- Patients with prior chemotherapy and Doxil exposure are eligible

- Age >=18

- Karnofsky score of >=70%

- Hemoglobin >=8 g/dl, neutrophil count >=1000 cells/ul and platelet count of >=75,000
cells/ul.

- Creatinine clearance of .=50 ml/min or creatinine of <=2.0mg/dl, SGOT <=2X the
institutional normal and bilirubin <1.5X institutional normal

- Written informed consent has been obtained from the patient.

EXCLUSION CRITERIA

- Pregnant or breast feeding patients as radioactive tracer material and chemotherapy
will be used in this protocol.

- Active opportunistic infections requiring antibiotic treatment.

- Treatment with radiation or electron beam therapy, interferon or cytotoxic therapy
within the preceding 4 weeks.

- Clinically significant history of congestive heart failure.

- Patients who have moderate to severe sensory and motor peripheral neuropathy.

- Any patient currently receiving treatment with any of the following agents which
cannot be discontinued at a specified time relative to PSC 833 administration. All of
these drugs are well substantiated to interact with cyclosporin A:

- Agents increasing serum concentrations of CsA

The following drugs must not be administered for 48 hours before PSC 833 is started,
during the course of its administration, or up to 48 hours after the last dose of PSC 833
in a cycle:

Calcium channel blockers: diltiazem, nicardipine, verapamil Antifungals: fluconazole (dose
<200 mg/day allowed), itraconazole, ketoconazole Antibiotics: clarithromycin, erythromycin
Others: metoclopramide,bromocriptine, danazol

- Agents decreasing serum concentrations of CsA

The following drugs must not be administered in the 14 days before PSC 833 is started or
during the course of its administration. They may be restarted immediately after the last
dose of PSC 833:

Antibiotics: nafcillin, rifampin Anticonvulsants: carbamazepine, phenobarbital, phenytoin
Others: octreotide, ticlopidine

- Hypersensitivity to Doxil or cyclosporin A

- Any patient, who, in the judgment of the investigator, may not be able to complete
this study.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Outcome Measure:

Safety profile and tolerability of Doxil in combination with PSC 833

Outcome Description:

Each cycle is 2 weeks long and can continue until disease progression, toxicity, or patient decision

Safety Issue:

Yes

Principal Investigator

Paula M. Fracasso, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Food and Drug Adminstration

Study ID:

CDR0000066062

NCT ID:

NCT00003207

Start Date:

March 1998

Completion Date:

July 2002

Related Keywords:

  • Sarcoma
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • AIDS-related Kaposi sarcoma
  • recurrent Kaposi sarcoma
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110