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SarcomaPhase 1NCT00003720

SU5416 in Treating Patients With AIDS-Related Kaposi's Sarcoma

A Phase 1 study testing semaxanib in people with Sarcoma, run by Pfizer at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: SU5416 may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of SU5416 in treating patients who have AIDS-related Kaposi's sarcoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma
What is being tested?
semaxanib
How many people
Not given
Where
4 sitesUnited States
Study dates
Jul 1998to not given
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS: Biopsy proven Kaposi's sarcoma that is stable or progressing while receiving standard therapy HIV positive No severe pulmonary Kaposi's sarcoma Five measurable lesions of at least 10 mm or lesions present for at least 30 days OR KS-related generalized edema or edema of the extremities without evidence of active mucocutaneous lesions

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 750/mm3 without transfusion Hemoglobin at least 8.0 g/dL without transfusion Platelet count at least 50,000/mm3 without transfusion Hepatic: AST/ALT no greater than 2.5 times upper limit of normal (ULN) Bilirubin no greater than 2.0 mg/dL (3.0 mg/dL if concurrent indinavir therapy) Renal: Creatinine no greater than 1.8 mg/dL OR Creatinine clearance at least 50 mL/min Other: Not pregnant Fertile patients must use effective contraception No known allergy to Cremophor or Cremophor based drug product No concurrent uncontrolled serious infection such as: Pneumocystis carinii pneumonia Toxoplasma brain abscess CMV retinitis or colitis Cryptococcal meningitis Symptomatic Mycobacterium avium-intracellulare No other active malignancy except: Basal cell carcinoma of the skin Carcinoma in situ of the cervix No other acute or chronic medical or psychiatric condition

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior biologic therapy for AIDS-related Kaposi's sarcoma At least 2 weeks since prior immunotherapy for AIDS-related Kaposi's sarcoma and recovered At least 2 weeks since prior epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) No concurrent immunotherapy Chemotherapy: At least 2 weeks since prior chemotherapy for AIDS-related Kaposi's sarcoma and recovered No concurrent chemotherapy Endocrine therapy: At least 2 weeks since prior hormonal therapy for AIDS-related Kaposi's sarcoma No concurrent hormonal therapy (including beta-HCG) Radiotherapy: Recovered from prior radiotherapy No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery and recovered No prior biopsy of measurable lesion Other: No prior laser therapy to measurable lesion Stable antiretroviral therapy for at least 2 weeks At least 3 weeks since other investigational drugs No concurrent local or topical therapy for disease No other concurrent investigational agents

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033-0800

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • Kaplan Cancer Center

    New York, New York, 10016

  • St. Francis Hospital

    San Francisco, California, 94109

Other trials in United States

About this study

Official title: A Multicenter, Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma

RATIONALE: SU5416 may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of SU5416 in treating patients who have AIDS-related Kaposi's sarcoma.

Read the detailed description

OBJECTIVES: I. Evaluate the safety and tolerability of SU5416 in patients with AIDS-related Kaposi's sarcoma. II. Determine the pharmacokinetics of this regimen in these patients. III. Evaluate the antitumor effects and biological activity of this regimen in these patients. IV. Determine the safety of this regimen on HIV replication and immune parameters in these patients.

OUTLINE: This is a dose escalation, multicenter study. Patients receive SU5416 by intravenous injection twice weekly for 4 weeks. Patients may continue treatment for a maximum of 1 year in the absence of disease progression and unacceptable toxicity. In the absence of dose limiting toxicity (DLT) in the first 6 patients treated, subsequent cohorts of 6 patients each receive escalating doses of SU5416 on the same schedule. If DLT occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose (MTD). Six additional patients are treated at the MTD. Patients are followed at 30 days after the last treatment, and every 3 months thereafter.

PROJECTED ACCRUAL: This study will accrue a maximum of 30 patients.

Conditions
Sarcoma
Being tested
semaxanib
Keywords
AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma
Medical subject headings
Sarcoma, AIDS-related Kaposi sarcoma, Sarcoma, Kaposi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • semaxanibDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2004 (estimated)
  2. Study startJul 1998

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003720
Sponsor's protocol ID
SUGEN-SU5416.003
Other IDs
CDR0000066829, LAC-USC-17K981
Status last verified
Aug 2012
First submitted
1 Nov 1999
Last updated
23 Aug 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing semaxanib in people with Sarcoma, run by Pfizer at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2012.

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