AzTrials
AzTrials

SarcomaPhase 2NCT00019240

Antiviral Therapy in Treating Patients With Kaposi's Sarcoma With or Without HIV Infection

A Phase 2 study testing cidofovir in people with Sarcoma, run by National Cancer Institute (NCI) at 1 site 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: Herpesvirus is found in Kaposi's sarcoma lesions in most patients; it is therefore possible that the herpesvirus has a role in causing Kaposi's sarcoma. Cidofovir is an antiviral drug that acts against many types of herpesvirus, and may be an effective treatment for 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?
cidofovir
How many people
Not given
Where
1 siteUnited States
Study dates
Nov 1996to Apr 2004
Phase
Phase 2
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 (KS) HIV infection (measured by ELISA and Western blot) allowed NCI pathology review required At least 5 measurable lesions required No prior local therapy to indicator lesions Lesions evaluable by noninvasive methods No actively bleeding or critically located KS of immediate risk to patient or at the discretion of the Principal Investigator and/or Study Chairperson No pulmonary or other potentially acutely life-threatening KS lesions

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: More than 3 months Hematopoietic: Absolute neutrophil count at least 750/mm3 Platelet count at least 75,000/mm3 Hemoglobin at least 11 g/dL (10 g/dL in women) CD4 count greater than 50 cells per cubic millimeter Hepatic: Bilirubin no greater than 1.5 times normal (unless due to Gilbert's disease) Patients on protease inhibitors may have bilirubin no greater than 3.5 mg/dL (direct bilirubin no greater than 0.2 mg/dL) AST/ALT no greater than 75 IU/mL Alkaline phosphatase no greater than 2.5 times normal Renal: Creatinine less than 1.5 mg/dL Creatinine clearance (calculated) greater than 55 mL/min Proteinuria less than 2+ Cardiovascular: No significant EKG abnormality Other: No actively life-threatening infection At least 14 days since treatment for serious infection No known clinically significant allergy to probenecid or sulfa No grade 3 or worse clinical or laboratory toxicity other than lymphopenia No medical condition that precludes protocol treatment or informed consent No second malignancy within 1 year except basal cell skin cancer No pregnant or nursing women Negative pregnancy test required of fertile women within 1 week prior to entry, every 4 weeks while on study, and 4 weeks after last treatment Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY: At least 1 week since treatment with any of the following: Diuretics Vidarabine Amphotericin B Aminoglycoside antibiotics Intravenous pentamidine Other known or potentially nephrotoxic agents Other investigational agents with anti-herpesvirus activity At least 4 weeks since systemic or local anti-herpesvirus therapy other than mucocutaneous acyclovir cream At least 4 weeks since systemic therapy for KS or other systemic or cutaneous malignancy At least 1 month since discontinuation of antiretroviral therapy Concurrent antiretroviral therapy allowed provided doses of the following, either alone or in combination, stable for at least 1 month prior to entry: AZT ddC 3TC ddI d4T protease inhibitor

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Medicine Branch

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: PHASE II PROTOCOL WITH LABORATORY CORRELATES OF 1-[(S)-3-HYDROXY-2-(PHOSPHOMETHOXY)PROPYL]CYTOSINE DIHYDRATE(CIDOFOVIR) IN PATIENTS WITH KAPOSI'S SARCOMA (KS)

RATIONALE: Herpesvirus is found in Kaposi's sarcoma lesions in most patients; it is therefore possible that the herpesvirus has a role in causing Kaposi's sarcoma. Cidofovir is an antiviral drug that acts against many types of herpesvirus, and may be an effective treatment for Kaposi's sarcoma.

PURPOSE: Phase II trial to study the effectiveness of cidofovir in treating patients with Kaposi's sarcoma with or without HIV infection.

Read the detailed description

OBJECTIVES: I. Assess the antitumor activity of intravenous cidofovir in patients with Kaposi's sarcoma (KS) with and without human immunodeficiency virus (HIV) infection. II. Assess the effect of intravenous cidofovir on the load of KS-associated herpesvirus/human herpesvirus-8 in KS lesions and peripheral blood mononuclear cells by quantitative polymerase chain reaction. III. Assess the toxicity of cidofovir in KS patients with and without HIV infection. IV. Assess the effect of cidofovir on angiogenic cytokines related to the pathogenesis of KS.

OUTLINE: All patients receive intravenous cidofovir weekly for 2 weeks, then every other week for 6 months. Patients with a complete or partial response may continue treatment until disease progression intervenes.

PROJECTED ACCRUAL: Up to 25 evaluable patients will be entered over approximately 6 months if there are at least 2 responses in the first 15 patients.

Conditions
Sarcoma
Being tested
cidofovir
Keywords
classic Kaposi sarcoma, 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.

  • cidofovirDrug

Timeline

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

  1. First posted21 Apr 2004 (estimated)
  2. Study startNov 1996
  3. Study completionApr 2004

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 2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00019240
Sponsor's protocol ID
CDR0000065260
Other IDs
NCI-97-C-0024C
Status last verified
Nov 2007
First submitted
11 Jul 2001
Last updated
20 Jun 2013
Results posted
No

Publications

  • Kedes DH, Ganem D. Sensitivity of Kaposi's sarcoma-associated herpesvirus replication to antiviral drugs. Implications for potential therapy. J Clin Invest. 1997 May 1;99(9):2082-6. doi: 10.1172/JCI119380.

    PubMed 9151779

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cidofovir in people with Sarcoma, run by National Cancer Institute (NCI) at 1 site 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 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

On the ClinicalTrials.gov record for NCT00019240, which also lists 1 linked publication.

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 20 Jun 2013.

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