SarcomaNCT00096538
Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposi's Sarcoma
A study testing valganciclovir in people with Sarcoma, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
Trial summary
RATIONALE: Herpesvirus is found in the lesions of most patients with Kaposi's sarcoma, and may have a role in causing Kaposi's sarcoma. Valganciclovir is an antiviral drug that acts against many types of herpesviruses and may be an effective treatment for Kaposi's sarcoma. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Sarcoma
- What is being tested?
- valganciclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2004to Feb 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed classic Kaposi's sarcoma (KS) involving the skin
- Non-HIV-associated disease
- HIV negative
- Measurable disease
- At least 8 KS lesions with ≥ 5 marker lesions measurable in 2 dimensions AND ≥ 3 other lesions measuring ≥ 1 cm in diameter
- Two 3 mm punch biopsies of a non-marker lesion entirely composed of KS
- Irradiated cutaneous lesions may not be used as indicator lesions
- No known active visceral KS or symptomatic KS-related edema that would preclude function or require cytotoxic chemotherapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- At least 12 months
Hematopoietic
- Hemoglobin ≥ 8 g/dL
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 3 times ULN
Renal
- Creatinine clearance ≥ 50 mL/min
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months after study participation
- No hypersensitivity to valganciclovir or ganciclovir
- No other neoplasia requiring cytotoxic therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 4 weeks since prior biological therapy for KS
- No concurrent immunotherapy
Chemotherapy
- More than 4 weeks since prior chemotherapy for KS
- No concurrent chemotherapy
Endocrine therapy
- No concurrent corticosteroid treatment except for replacement doses (equivalent to 20 mg of hydrocortisone per day)
Radiotherapy
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy for KS
- No concurrent radiotherapy
Surgery
- Not specified
Other
- More than 14 days since prior acute treatment for infection (other than oral thrush or genital herpes) or other serious medical illness
- More than 60 days since prior local therapy for any KS indicator lesion unless the lesion showed documented progression since treatment
- More than 4 weeks since prior local therapy for KS
- More than 4 weeks since prior investigational agents
- More than 4 weeks since other prior antineoplastic therapy for KS
- No other concurrent antiviral therapy
- No other concurrent investigational agents
- No other concurrent systemic therapy for KS
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
Memorial Sloan - Kettering Cancer Center
New York, New York, 10021
New York Weill Cornell Cancer Center at Cornell University
New York, New York, 10021
About this study
Official title: Pilot Study Of Valganciclovir In Patients With Classic, Non-HIV-Associated Kaposi's Sarcoma
RATIONALE: Herpesvirus is found in the lesions of most patients with Kaposi's sarcoma, and may have a role in causing Kaposi's sarcoma. Valganciclovir is an antiviral drug that acts against many types of herpesviruses and may be an effective treatment for Kaposi's sarcoma.
PURPOSE: This clinical trial is studying how well valganciclovir works in treating patients with classic non-HIV-associated Kaposi's sarcoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the antitumor activity of valganciclovir in patients with classic non-HIV-associated Kaposi's sarcoma (KS).
Secondary
- Determine the effect of this drug on lytic and latent human herpesvirus-8 gene expression in KS lesions of these patients.
- Determine the effect of this drug on the markers of angiogenesis in KS lesions of these patients.
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is a pilot study.
Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity.
All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 1 year.
- Conditions
- Sarcoma
- Being tested
- valganciclovir
- Keywords
- classic Kaposi sarcoma, recurrent Kaposi sarcoma
- Medical subject headings
- Sarcoma, Sarcoma, Kaposi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valganciclovirDrug
| Study group | Role | What they receive |
|---|---|---|
| valganciclovir | Experimental | Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year. Receives: Drug: valganciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response Rate Every 4 Weeks
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2004 (estimated)
- Study startApr 2004
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), New York Presbyterian Hospital, Weill Medical College of Cornell University, University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Susan E. Krown, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096538
- Sponsor's protocol ID
- 04-055
- Other IDs
- MSKCC-04055
- Status last verified
- Oct 2015
- First submitted
- 9 Nov 2004
- Last updated
- 25 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Of Valganciclovir In Patients With Classic, Non-HIV-Associated Kaposi's Sarcoma
- ClinicalTrials.gov ID
- NCT00096538
- Acronym / sponsor ID
- 04-055
- Conditions
- Sarcoma
- Keywords
- classic Kaposi sarcoma, recurrent Kaposi sarcoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), New York Presbyterian Hospital, Weill Medical College of Cornell University, University of North Carolina, Chapel Hill
- Study start
- Apr 2004
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 10 Nov 2004 (estimated)
- Results
- Posted 25 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Herpesvirus is found in the lesions of most patients with Kaposi's sarcoma, and may have a role in causing Kaposi's sarcoma. Valganciclovir is an antiviral drug that acts against many types of herpesviruses and may be an effective treatment for Kaposi's sarcoma.
PURPOSE: This clinical trial is studying how well valganciclovir works in treating patients with classic non-HIV-associated Kaposi's sarcoma.
Detailed description
OBJECTIVES:
Primary
- Determine the antitumor activity of valganciclovir in patients with classic non-HIV-associated Kaposi's sarcoma (KS).
Secondary
- Determine the effect of this drug on lytic and latent human herpesvirus-8 gene expression in KS lesions of these patients.
- Determine the effect of this drug on the markers of angiogenesis in KS lesions of these patients.
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is a pilot study.
Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity.
All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| valganciclovir | Experimental | Drug: valganciclovirPatients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| valganciclovir | Drug | valganciclovir |
Primary outcome
Tumor Response Rate Every 4 Weeks
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan E. Krown, MD study chair
Memorial Sloan Kettering Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing valganciclovir in people with Sarcoma, run by Memorial Sloan Kettering Cancer Center at 3 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 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Tumor Response Rate Every 4 Weeks (time frame: 2 years). It is what the study was designed to measure, not a finding.
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 25 Nov 2015.