sEphB4-HSA for Kaposi Sarcoma

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen byIda Wong-Sefidan

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AIDS Malignancy Consortium

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase II trial studies recombinant EphB4-HSA fusion protein (EphB4-HSA) in treating patients with Kaposi sarcoma. Recombinant EphB4-HSA fusion protein may block the growth of blood vessels that provide blood to the cancer, and may also prevent cancer cells from growing.

Eligibility Criteria

This trial is for individuals with Kaposi Sarcoma, which may include those who haven't been treated before or those who didn't respond to or couldn't tolerate previous treatments. HIV-positive participants are welcome if they're on stable antiretroviral therapy. Participants need a life expectancy over 3 months and must have skin lesions suitable for biopsy. They should not be pregnant and must agree to use effective birth control methods.

Inclusion Criteria

You are expected to live for more than 3 months.

Participants must, in the opinion of the investigator, be capable of complying with the protocol

I have Kaposi's sarcoma confirmed by a biopsy, affecting my skin and possibly other organs.

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Exclusion Criteria

Participants who are receiving any other investigational agents

I do not have severe diabetes, COPD requiring recent hospitalization, or conditions that make treatment risky for me.

I have not had a serious infection or been treated for one in the last 14 days.

See 26 more

Treatment Details

Interventions

Recombinant EphB4-HSA Fusion Protein (Virus Therapy)

Trial OverviewThe study is testing the effects of recombinant EphB4-HSA fusion protein on Kaposi Sarcoma. This treatment aims to block blood vessel growth that feeds cancer cells and prevent the cancer cells from growing further.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (recombinant EphB4-HSA fusion protein)Experimental Treatment4 Interventions

Patients receive recombinant EphB4-HSA fusion protein IV over 1 hour on days 1 and 15. Patients with disease progression after 2 or more courses who have not experienced toxicity may receive recombinant EphB4-HSA fusion protein IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of further disease progression or unacceptable toxicity.