Temozolomide + Peginterferon for Melanoma

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen ByAlberto S. Pappo

Age: < 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: St. Jude Children's Research Hospital

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The main goal of this study is to estimate the tumor response rate of temozolomide administered in combination with peginterferon alfa-2b to pediatric patients with unresectable Stage III, metastatic, or recurrent cutaneous melanoma.

Eligibility Criteria

This trial is for children up to 21 years old with high-risk melanoma that can't be removed by surgery or has spread. They must have good liver, kidney, and bone marrow function and no history of severe depression, uncontrolled infections, certain heart diseases, poorly controlled diabetes or thyroid conditions. Prior treatment with dacarbazine or temozolomide disqualifies them.

Inclusion Criteria

My melanoma is at an advanced stage or has come back.

My bone marrow is working well.

I was diagnosed at 21 years old or younger.

Exclusion Criteria

My diabetes is not well-managed with my current medication.

I have been hospitalized for depression or other mental health issues.

My thyroid condition is not well-managed with medication.

I have a history of severe heart or blood vessel problems.

I do not have any infections that are currently uncontrolled.

I have been treated with dacarbazine or temozolomide before.

I have autoimmune hepatitis.

Participant Groups

The study tests the effectiveness of combining two drugs: Temozolomide and Peginterferon alfa-2b in treating pediatric patients with advanced melanoma. The aim is to see how well tumors respond to this combination therapy.

2Treatment groups

Experimental Treatment

Group I: Temozolomide/peginterferon alfa-2bExperimental Treatment2 Interventions

Stratum B: Resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent patients Stratum B is divided into 2 groups based on the presence (Stratum B1) or absence (Stratum B2) of measurable disease. Subjects will receive 8 weekly doses of peginterferon alfa-2b 0.5 mcg/kg/dose subcutaneously (SQ) in combination with temozolomide 75mg/m2/dose by mouth (PO) daily for 6 weeks followed by 2 week break. The duration of each treatment course will be 8 weeks. Strata B2 (no measurable disease) will proceed with 7 courses as outlined.

Group II: Peginterferon alfa-2b/non-pegylated interferon alfa-2bExperimental Treatment3 Interventions

Stratum A: Resected Stages IIC, IIIA, and IIIB patients will receive recombinant interferon alfa-2b 20 million units/m2/day intravenously (IV) 5 consecutive days per week for 4 weeks followed by peginterferon alfa-2b 1mcg/kg subcutaneously (SQ) once a week for 48 weeks.