HIV
- Related Malignancy Trials
|
| TITLE |
AMC 042 A Phase II Trial of Imatinib Mesylate (Gleevec) in Patients with HIV-Related
Kaposi's Sarcoma |
| DESCRIPTION |
This study is being done to valuate the clinical response to imatinib mesylate
(Gleevec) in patients with AIDS-related Kaposi’s sarcoma. Patients will be given the
drug Gleevec orally once a day, and may continue on the study protocol as long as
their Kaposi’s sarcoma is stable or responding up to six months. Patients who are
responding or have stable disease at 6 months may continue on the study for an
additional 6 months. |
| ELIGIBILITY |
- Patients must have a confirmed diagnosis of Kaposi’s sarcoma involving the
skin, lymph nodes, oral cavity, gastrointestinal tract and/or lungs. GI and
pulmonary involvement must be asymptomatic or minimally symptomatic and not require
systemic cytotoxic therapy.
- Patients must have documented HIV infection at the time of entry into the
study.
- Patients must have adequate bone marrow, liver and kidney function.
- Patients must have a life expectancy of 3 months or longer.
- Anti-retroviral therapy is required for patients except those who have
exhausted all available treatment options.
|
| CONTACT |
Anne Ness, RN 216-844-1637 |
|
| TITLE |
CWRU 5Z03 Open-Label Prospective Trial Evaluating the Toxicities Associated with Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities |
| DESCRIPTION |
This study will determine treatment related toxicities and safety profile of subcutaneous administration of amifostine for the prevention of radiation-induced toxicities. Patients will receive Amifostine 2 hours prior to each daily radiation treatment. |
| ELIGIBILITY |
- Patients must be eligible to receive subcutaneous amifostine under the site’s current practice guidelines for radioprotection.
- Patients must be receiving radiation therapy or combined modality therapy for definitive treatment of head and neck cancer.
- Patients may not be entered on investigational therapeutic trials.
- Patients must have normal bone marrow and liver function.
|
| CONTACT |
Leda Dumadag
,
RN 216-844-5829 |
|
| TITLE |
AMC 038: A Pilot Trial of Valproic Acid in Patients with Kaposi’s Sarcoma |
| DESCRIPTION |
This study will determine the safety of valproic acid in patients with Kaposi’s sarcoma. A prescription for valproic acid will be prescribed at study entry. Patients will be started on one capsule two times a day. After 2 days the dose will be increased. After two more, days the dose will be increased again. Patients will take valproic acid for 28 days, and then begin to taper by reducing the dose each week until drug is totaling discontinued. |
| ELIGIBILITY |
- Patients must have histologically confirmed Kaposi’s sarcoma, HIV related, not requiring systemic treatment (radiation or chemotherapy) less than 2 weeks before enrollment.
- Patients must have a life expectancy of at least 3 months.
- Patients receiving antiretroviral therapy should be on a stable regimen for at least 4 weeks prior to study entry.
- Patients must not have concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within 14 days of enrollment.
- Patients must have normal bone marrow, kidney and liver function.
|
| CONTACT |
Anne Ness, RN 216-844-1637 |
|
| TITLE |
AMC
036: A
Phase II Trial of Topical Halofugione in Patients with HIV
Related Kaposi’s Sarcoma
|
| DESCRIPTION |
This
study will determine the tumor response rate of AIDS-related
Kaposi’s sarcoma to topical halofuginone versus vehicle
control.
All patients and clinical investigators participating
in this trial will be blinded with respect to treatment.
Patients will be assigned to receive either
halofuginone or placebo ointment.
Patients will receive twice-daily topical
administration of halofuginone or placebo ointment.
Patients may remain on blinded study for a maximum of
12 weeks or until one of the criteria for discontinuation is
met.
|
| ELIGIBILITY
|
-
Patients
must have biopsy-proven Kaposi’s sarcoma with at least
14 cutaneous lesions.
-
Patients
must have serologic documentation of HIV infection.
-
Patients
must have adequate bone marrow, renal and hepatic
function.
-
Patients
must have a life expectancy of at least 3 months.
-
Patients
receiving antiretroviral therapy must be on a stable
regimen for at least 12 weeks prior to study entry without
showing evidence of ongoing KS regression.
-
Patients
must not have received anti-neoplastic treatment for
Kaposi’s sarcoma including chemotherapy, radiation
therapy, local therapy, biological therapy or
investigational therapy) within 4 weeks of study entry.
-
Patients
must not have received previous local therapy of any
KS-indicator lesion within 60 days unless the lesion has
clearly progressed since treatment.
|
| CONTACT |
Anne Ness, RN 216-844-1637 |
| |
