Sarcoma, KaposiPhase 2NCT00002314
A Study of Ro 24-7429 in Patients With HIV-Related Kaposi's Sarcoma
A Phase 2 study testing Ro 24-7429 in people with Sarcoma, Kaposi and HIV Infections, run by Hoffmann-La Roche at 2 sites in United States.
Trial summary
To study the effects of Ro 24-7429 on tumor growth in patients with HIV-related Kaposi's sarcoma. To study the safety and tolerance, effects on HIV replication, and immunologic effects of Ro 24-7429 in this patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Kaposi, HIV Infections
- What is being tested?
- Ro 24-7429
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- 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
Who may be able to join
- Patients must have:
- HIV seropositivity.
- Biopsy-proven mucocutaneous Kaposi's sarcoma with fewer than 50 skin lesions and measurable disease.
- No active opportunistic infection. NOTE:
- Patients with CD4 count >= 200 cells/mm3 must have no prior opportunistic infection, as well as no active opportunistic infection.
- Life expectancy of at least 24 weeks.
- Stable weight (+/- 2 kg) by 28 days prior to study entry.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Other active malignancies (except basal cell carcinoma of the skin and in situ cervical cancer).
- Known or suspected hypersensitivity to benzodiazepines.
- Evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, dermatologic, or allergic disease as determined by the investigator.
- Ongoing diarrhea (> two liquid stools per day).
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- Grade 2 or worse signs and symptoms of AIDS Dementia Complex.
- Alteration of mental status that may interfere with study compliance.
- Concurrent Medication:
- Excluded:
- AZT, ddI, or ddC.
- Experimental antiretrovirals.
- Biologic response modifiers or immunomodulating agents (e.g., interferon).
- Colony stimulating factors (erythropoietin, GM-CSF, G-CSF).
- Ganciclovir.
- Foscarnet.
- H-2 antagonists (cimetidine, ranitidine, famotidine, nizatidine).
- Omeprazole.
- Benzodiazepines.
- Any other investigational compound.
- Ongoing systemic treatment with corticosteroids (other than replacement therapy for adrenal insufficiency or short-term therapy of no more than 28 days for bronchial asthma).
- Cytotoxic chemotherapy (systemic and local).
- Drugs known to cause systemic toxicity, if avoidable (e.g., myelosuppressive, hepatotoxic, nephrotoxic, or neurotoxic drugs).
- Paromomycin sulfate.
- Chronic suppressive therapy for CMV and/or MAI.
- Patients with the following prior condition are excluded:
- History of serious adverse reactions to benzodiazepines.
- Prior Medication:
- Excluded:
- Interferons or immune modulators within 4 weeks prior to study entry.
- Prior systemic cytotoxic chemotherapy (patients with CD4 counts >= 200 cells/mm3 only).
- Benzodiazepines within 14 days prior to study entry.
- Intralesional chemotherapy for Kaposi's sarcoma within 2 weeks prior to study entry.
- Therapy with antiretroviral drugs (including AZT, ddI, ddC, d4T) or investigational drugs within 14 days prior to study entry.
- Localized radiotherapy. Radiotherapy (other than localized). Active drug or alcohol abuse.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New England Deaconess Hosp
Boston, Massachusetts, 02215
CARE Ctr / UCLA Med Ctr
Los Angeles, California, 900951793
About this study
Official title: A Phase II Study of Oral Ro 24-7429 (Tat Antagonist) in Patients With HIV-Related Kaposi's Sarcoma
To study the effects of Ro 24-7429 on tumor growth in patients with HIV-related Kaposi's sarcoma. To study the safety and tolerance, effects on HIV replication, and immunologic effects of Ro 24-7429 in this patient population. To explore relationships between exposure to Ro 24-7429 and its metabolites with its antitumor and antiviral activities and drug toxicity.
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Being tested
- Ro 24-7429
- Keywords
- Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Antineoplastic Agents, Gene Products, tat
- Medical subject headings
- Sarcoma, Kaposi, HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ro 24-7429Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoma, KaposiStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 2
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002314
- Sponsor's protocol ID
- 128A
- Status last verified
- Dec 1993
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Oral Ro 24-7429 (Tat Antagonist) in Patients With HIV-Related Kaposi's Sarcoma
- ClinicalTrials.gov ID
- NCT00002314
- Acronym / sponsor ID
- 128A
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Keywords
- Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Antineoplastic Agents, Gene Products, tat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (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.
To study the effects of Ro 24-7429 on tumor growth in patients with HIV-related Kaposi's sarcoma. To study the safety and tolerance, effects on HIV replication, and immunologic effects of Ro 24-7429 in this patient population. To explore relationships between exposure to Ro 24-7429 and its metabolites with its antitumor and antiviral activities and drug toxicity.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HIV seropositivity.
- Biopsy-proven mucocutaneous Kaposi's sarcoma with fewer than 50 skin lesions and measurable disease.
- No active opportunistic infection. NOTE:
- Patients with CD4 count >= 200 cells/mm3 must have no prior opportunistic infection, as well as no active opportunistic infection.
- Life expectancy of at least 24 weeks.
Key exclusion criteria (35 listed)
- Other active malignancies (except basal cell carcinoma of the skin and in situ cervical cancer).
- Known or suspected hypersensitivity to benzodiazepines.
- Evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, dermatologic, or allergic disease as determined by the investigator.
- Ongoing diarrhea (> two liquid stools per day).
- Grade 2 or worse signs and symptoms of AIDS Dementia Complex.
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 |
|---|---|---|
| Ro 24-7429 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ro 24-7429 in people with Sarcoma, Kaposi and HIV Infections, run by Hoffmann-La Roche at 2 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?
The sponsor lists 7 inclusion and 35 exclusion criteria. 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
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 24 Jun 2005.