Cediranib for Sarcoma

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Anticonvulsants, Antiretrovirals, others

Disqualifiers: Uncontrolled hypertension, Diabetes, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 16.9 cycles for adults, 34.7 cycles for pediatric patients

53 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Background: * Alveolar soft part sarcoma is a type of cancer that develops in tissues that connect, support, or surround other organs in the body. It relies heavily on new blood vessels to grow and spread through the body. There is no effective systemic treatment for patients with alveolar soft part sarcoma. * The drug AZD2171 (cediranib) is an experimental drug, not yet approved by the Food and Drug Administration. The drug blocks the creation of new blood vessels. The drug has had initial clinical trials, and researchers are interested in determining whether cediranib is effective in inhibiting tumor growth in individuals who have alveolar soft part sarcoma. Objectives: - To find out whether AZD2171 works in patients who have alveolar soft part sarcoma. Eligibility: - Individuals 18 years of age and older who have been diagnosed with alveolar soft part sarcoma. Design: * After an initial screening visit, patients will take AZD2171 by mouth once a day, every day for the duration of the study. The treatment will be given in 28-day cycles. * Patients will keep a study diary to record the doses taken, any missed doses, and any side effects. * Patients will have the following tests and procedures during the treatment period: clinic visit with physical examination every 2 weeks during cycles 1 and 2, then at the start of each subsequent cycle, regular blood pressure monitoring, blood and urine tests, heart function tests, imagining scans to evaluate tumor size and response to the treatment, and possible tumor biopsy.

Who Is on the Research Team?

Alice P Chen, M.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

Adults diagnosed with alveolar soft part sarcoma can join this trial. They must have a tumor that's measurable on scans, be in relatively good health, and not pregnant or breastfeeding. Participants need to have normal organ function and blood pressure, and cannot be taking certain drugs that affect kidney function or interact with the study drug.

Inclusion Criteria

Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 millimeters with conventional techniques or as greater than or equal to 10 millimeters with spiral computed tomography (CT) scan.

Body surface area (BSA) greater than or equal to 1.04 square meter.

Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 for adults, Karnofsky performance status greater than or equal to 50% for pediatric patients greater than 10 years of age, and Lansky performance status greater than or equal to 50 for pediatric patients less than or equal to 10 years of age.

Exclusion Criteria

Mean QTc greater than 500 msec (with Bazett's correction) in screening electrocardiogram or history of familial long Q wave, T wave (QT) syndrome.

Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart.

Pregnant women are excluded from this study because AZD2171 is a VEGF inhibitor with known abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AZD2171, breastfeeding should be discontinued if the mother is treated with AZD2171.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AZD2171 by mouth once a day in 28-day cycles. Adult patients receive 30 mg daily, while pediatric patients receive 12 mg/m² daily.

16.9 cycles for adults, 34.7 cycles for pediatric patients

Clinic visit every 2 weeks during cycles 1 and 2, then at the start of each subsequent cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment, including CT scans for restaging and blood pressure monitoring.

4 weeks

Optional Biopsy

Optional biopsies performed in adult patients at baseline, after 3-5 days of treatment, and after completion of 4 weeks of therapy to evaluate drug effect.

What Are the Treatments Tested in This Trial?

Interventions

• Cediranib (AZD2171)

Trial Overview The trial is testing AZD2171 (cediranib), an experimental drug designed to stop tumors from growing new blood vessels. Patients will take cediranib daily in 28-day cycles, recording doses and side effects in a diary. Their response to treatment will be monitored through regular clinic visits, tests, scans, and possibly biopsies.

How Is the Trial Designed?

Group I: Cediranib (AZD2171) Treatment Experimental Treatment 1 Intervention

Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles). Pediatric participants (\<16 years old) will be treated with 12 mg/m\^2/day once a day for 28 days (28-day cycles).

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+