SarcomaPhase 1NCT00006222
EMD 121974 in Treating Patients With HIV-Related Kaposi's Sarcoma
A Phase 1 study testing cilengitide in people with Sarcoma, run by National Cancer Institute (NCI) at 3 sites in United States.
Trial summary
Phase I trial to study the effectiveness of EMD 121974 in treating patients who have HIV-related Kaposi's sarcoma. EMD 121974 may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- cilengitide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2000to Mar 2001
- 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:
- Histologically proven Kaposi's sarcoma
- Systemic chemotherapy not required
- Minimum of 2 lesions amenable to biopsy
- Measurable or evaluable disease HIV positive
PATIENT CHARACTERISTICS:
- Age: 18 and over
- Performance status: Karnofsky 70-100%
- Life expectancy: At least 3 months
- Hemoglobin at least 8.0 g/dL
- Absolute neutrophil count at least 750/mm3
- Platelet count at least 75,000/mm3
- PT/PTT normal Bilirubin normal (bilirubin no greater than 3.5 mg/dL if secondary to indinavir therapy, provided direct bilirubin no greater than upper limit of normal (ULN))
- AST (SGOT) no greater than 2.5 times ULN
- Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min
- No prior ischemic coronary artery disease including prior myocardial infarction
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study
- No concurrent active infection (nonsystemic infection, e.g., herpes simplex, oral thrush, or warts, allowed)
- No gastric or duodenal ulcer within past 6 weeks unless healed
PRIOR CONCURRENT THERAPY:
- At least 2 weeks since prior antineoplastic biologic therapy and recovered
- At least 3 weeks since prior myeloid growth factor
- Growth factors and transfusion allowed if dose requirement is stable for 4 weeks prior to therapy
- At least 2 weeks since prior chemotherapy (6 weeks since prior nitrosourea or mitomycin) and recovered
- Concurrent hydroxyurea as antiretroviral therapy allowed if dose stable for 4 weeks prior to study
- No concurrent systemic cytotoxic chemotherapy
- Recovered from prior endocrine therapy
- At least 2 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
- At least 3 weeks since major surgery or 10 days since minor surgery and recovered
- At least 4 weeks since prior experimental therapy for Kaposi's sarcoma and recovered
- At least 2 weeks since prior local therapy to any indicator lesion
- No concurrent investigational drugs (except antiretroviral therapy)
- At least 2 weeks since prior acute treatment for infection or other serious medical illness
- Antiretroviral therapy must be stable for 4 weeks prior to study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
About this study
Official title: A Phase I Trial of EMD 121974 in Patients With HIV Related Kaposi's Sarcoma
Phase I trial to study the effectiveness of EMD 121974 in treating patients who have HIV-related Kaposi's sarcoma. EMD 121974 may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.
Read the detailed description
OBJECTIVES:
- Determine the safety and toxicity of EMD 121974 in patients with HIV related Kaposi's sarcoma.
II. Determine the antiangiogenic activity of this drug in these patients. III. Determine the antitumor activity of this drug in these patients. IV. Determine the effect of this drug on CD4 and CD8 cell counts and percentages, and on HIV viral load in these patients.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose escalation study.
Patients receive EMD 121974 IV twice a week for four weeks. Courses repeat every 4 weeks in the absence of disease progression. Cohorts of 3-6 patients receive escalating doses of EMD 121974 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities.
Patients are followed for at least 1 month.
PROJECTED ACCRUAL: A total of 18-30 patients will be accrued for this study within 1 year.
- Conditions
- Sarcoma
- Being tested
- cilengitide
- 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.
cilengitideDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive EMD 121974 IV twice a week for four weeks. Courses repeat every 4 weeks in the absence of disease progression. Cohorts of 3-6 patients receive escalating doses of EMD 121974 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities. Receives: Drug: cilengitide |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2004 (estimated)
- Study startSep 2000
- Primary completionMar 2001
- Study completionMar 2001
Why it stopped: Administratively complete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Barbara J. Klencke, MD, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006222
- Sponsor's protocol ID
- NCI-2012-02358
- Other IDs
- AMC-023, CDR0000068142
- Status last verified
- Apr 2001
- First submitted
- 11 Sep 2000
- Last updated
- 3 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of EMD 121974 in Patients With HIV Related Kaposi's Sarcoma
- ClinicalTrials.gov ID
- NCT00006222
- Acronym / sponsor ID
- NCI-2012-02358
- Conditions
- Sarcoma
- Keywords
- AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administratively complete.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Sep 2000
- Primary completion
- Mar 2001 (actual)
- Study completion
- Mar 2001 (actual)
- First posted
- 26 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I trial to study the effectiveness of EMD 121974 in treating patients who have HIV-related Kaposi's sarcoma. EMD 121974 may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.
Detailed description
OBJECTIVES:
- Determine the safety and toxicity of EMD 121974 in patients with HIV related Kaposi's sarcoma.
II. Determine the antiangiogenic activity of this drug in these patients. III. Determine the antitumor activity of this drug in these patients. IV. Determine the effect of this drug on CD4 and CD8 cell counts and percentages, and on HIV viral load in these patients.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose escalation study.
Patients receive EMD 121974 IV twice a week for four weeks. Courses repeat every 4 weeks in the absence of disease progression. Cohorts of 3-6 patients receive escalating doses of EMD 121974 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities.
Patients are followed for at least 1 month.
PROJECTED ACCRUAL: A total of 18-30 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 |
|---|---|---|
| Arm I | Experimental | Drug: cilengitidePatients receive EMD 121974 IV twice a week for four weeks. Courses repeat every 4 weeks in the absence of disease progression. Cohorts of 3-6 patients receive escalating doses of EMD 121974 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities. |
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| cilengitide | Drug | Arm I |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2013.
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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.
Barbara J. Klencke, MD study chair
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cilengitide in people with Sarcoma, run by National Cancer Institute (NCI) 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: stopped early, as of the sponsor's last update on 3 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 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.
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 was stopped early (reason given: Administratively complete.). Results are not available in the source record.
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 3 Jun 2013.