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Malignant MelanomaPhase 2NCT00539591

Phase II Study Incorporating Pegylated Interferon In the Treatment For Children With High-Risk Melanoma

A Phase 2 study testing Peginterferon alfa-2b, Temozolomide and Recombinant interferon alfa-2b in people with Malignant Melanoma, run by St. Jude Children's Research Hospital at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages Up to 21 years
Conditions the study is for
Malignant Melanoma
What is being tested?
Peginterferon alfa-2b, Temozolomide and Recombinant interferon alfa-2b
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
3 sitesUnited States
Study dates
9 May 2008to May 2031
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • AJCC stage IIC, III, IV or recurrent cutaneous melanoma
  • Adequate bone marrow function
  • Age less than or equal to 21 years of age at diagnosis
  • Adequate liver and kidney function

Who cannot join

  • Prior Therapy with dacarbazine or temozolomide
  • Patients who have uncontrolled infection
  • Patients with autoimmune hepatitis
  • Patients who have a history of depression or other psychiatric diseases requiring hospitalization
  • Patients taking systemic corticosteroids including oral steroids (i.e. prednisone, dexamethasone) or topical steroid creams/ointments. Steroid containing inhalers, steroid replacement for adrenal insufficiency and steroid premedication for prevention of transfusion or imaging contrast-agent related allergic reaction will be permitted.
  • Patients with hypersensitivity reaction to non-pegylated interferon α-2b are not eligible for study
Show all 9Show fewer
  • Patients with diabetes mellitus not adequately controlled with medication
  • Patients with hypo- or hyperthyroidism not adequately controlled with medication.
  • Patients with a history of myocardial infarction, severe or unstable angina, or severe peripheral vascular disease.

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • The Children's Cancer Hospital at UT M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

  • Rady Children's Hospital

    San Diego, California, 92123

Other trials in United States

About this study

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.

Read the detailed description

This study is for children with malignant melanoma and high risk features (at high risk of melanoma returning or spreading to other parts of the body) or who have recurrent disease. The study has two treatment groups based on the stage of the disease. Patients with stage IIC, IIIA or IIIB melanoma whose tumors have been removed by surgery will be treated in study group A. These patients will receive 4 weeks of high dose interferon alfa-2b followed by 48 weeks of peginterferon. Patients with stage IIIC or IV melanoma, stage III melanoma that could not be removed by surgery and those with recurrent disease will be treated in study group B. These patients will receive peginterferon alfa-2b and temozolomide.

Stratum A: Resected Stages IIC, IIIA, and IIIB patients

Induction therapy (weeks 1-4): Subjects will receive recombinant interferon alfa-2b 20 million units/m2 per day intravenously over 20-30 minutes on 5 consecutive days per week for 4 weeks. Subjects will receive peginterferon alfa-2b 1 mcg/kg/week subcutaneously for a total of 48 weeks.

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 in combination with temozolomide 75mg/m2/dose by mouth 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.

Surgery interventions -Associated with both Strata A and B Surgery description: All subjects with initial presentation of melanoma (T1-4) will be treated with primary wide local excision with a minimum of 1cm margin (if anatomically feasible) surrounding the primary lesion or biopsy scar. For lesions with Breslow's thickness of > 1mm or <or= with ulceration or Clark's level IV/V, a 2 cm margin is preferred when anatomically feasible. Subjects with sentinel lymph node(s) positive for disease, will undergo complete lymph node dissection of the involved nodal basin.

Additional objectives include:

  • To assess the safety of temozolomide administered in combination with peginterferon α-2b to pediatric patients with resected AJCC Stage IIIC, unresectable Stage III, metastatic, or recurrent cutaneous melanoma (Stratum B).
  • To study the feasibility and safety of administering peginterferon α-2b weekly for 48 weeks following an initial induction phase with intravenous high dose interferon α-2b for 4 weeks to pediatric patients with resected thick melanomas (> 4mm) with ulcerations (AJCC Stage IIC) and resected melanomas with regional lymph node metastases (AJCC Stage IIIA and IIIB) (Stratum A).
Being tested
Peginterferon alfa-2b, Temozolomide, Recombinant interferon alfa-2b
Keywords
Cutaneous Melanoma
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peginterferon alfa-2bDrug

    Also called PEG-Intron(R), pegylated interferon alfa-2b

    Given either IV or SQ. Therapeutic drug class: interferon.

  • TemozolomideDrug

    Also called Temodar(R), SCH 52365

    Given PO. Therapeutic drug class: antineoplastic agent.

  • Recombinant interferon alfa-2bDrug

    Also called Intron®, non-pegylated interferon alfa-2b

    Given IV. Therapeutic drug classes: antineoplastic agent, immunomodulatory agent, interferon

Study groups in NCT00539591
Study groupRoleWhat they receive
Temozolomide/peginterferon alfa-2bExperimentalStratum 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.
Receives: Drug: Peginterferon alfa-2b; Drug: Temozolomide
Peginterferon alfa-2b/non-pegylated interferon alfa-2bExperimentalStratum 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.
Receives: Drug: Peginterferon alfa-2b; Drug: Temozolomide; Drug: Recombinant interferon alfa-2b

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor Response Rate

    Tumor response rate of stratum B1 participants was evaluated after 1 treatment course of temozolomide plus peginterferon ɑ-2b. Complete response (CR) and partial response (PR) confirmed with repeated scan at least 4 weeks apart following completion of course 1 therapy. CR defined as disappearance of all target and non-target lesions with no new lesions detected. If available, no disease must be detected by immunocytology or serum tumor markers. PR defined as at least 30% decrease in disease measurement compared to disease measurement at study entry with no new lesions detected. Progressive disease (PD) defined as at least 20% increase in the disease measurement compared to the smallest disease measurement recorded since start of treatment, or appearance of one or more new lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD compared to smallest disease measurement since start of treatment.

    Measured: 8 weeks

  2. Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Strata B1 and B2

    The objective was to assess the safety of temozolomide administered in combination with peginterferon a-2b in Stratum B participants.

    Accrual was suspended any time during therapy if 2 or more of 6, 4 or more of 12, 6 or more of 18, 8 or more of 24, 10 or more of 30 participants experienced target toxicity defined as:

    • Grade 4 non-hematologic (non-hem) toxicity that does not resolve to ≤grade 1 within 2 weeks from the time next dose is due and is determined to be probably or definitely related to protocol therapy
    • Grade 4 non-hem toxicity that is NOT constitutional symptoms (fever, chills, fatigue and/or pain)
    • Grade 3 elevations in creatinine or BUN that are determined to be probably or definitely related to protocol therapy
    • Grade 4 cardiopulmonary toxicity that is determined to be probably or definitely related to protocol therapy
    • Grade 4 mood alteration (suicidal ideation; danger to self or others)

    Measured: 52 weeks

  3. Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Stratum A Patients

    The objective was to study the feasibility and safety of administering peginterferon a-2b weekly for 48 weeks following the initial induction phase to Stratum A participants.

    Accrual was suspended during the 48-week course if 2 or more of 6, 4 or more of 12, 6 or more of 18, 8 or more of 24, 10 or more of 30 participants experienced target toxicity defined as:

    • Grade 4 non-hematologic (non-hem) toxicity that does not resolve to ≤grade 1 within 2 weeks from the time next dose is due and is determined to be probably or definitely related to protocol therapy
    • Grade 4 non-hem toxicity that is NOT constitutional symptoms (fever, chills, fatigue and/or pain)
    • Grade 3 elevations in creatinine or BUN that are determined to be probably or definitely related to protocol therapy
    • Grade 4 cardiopulmonary toxicity that is determined to be probably or definitely related to protocol therapy
    • Grade 4 mood alteration (suicidal ideation; danger to self or others)

    Measured: 52 weeks

  4. Probability of Event-free Survival (EFS) of Stratum A Participants

    The probability of EFS was estimated as time to first event (relapse, death or second malignancy). As of April 2016, 21 out of 23 participants had no events. The EFS rate was estimated by Kaplan-Meier method.

    Measured: 3 years from diagnosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2007 (estimated)
  2. Study start9 May 2008
  3. Primary completionJun 2015
  4. Study completionMay 2031 (estimated)

Resources

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
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00539591
Sponsor's protocol ID
MEL06
Other IDs
NCI-2011-01192
Status last verified
Jun 2026
First submitted
2 Oct 2007
Last updated
25 Jun 2026
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Peginterferon alfa-2b, Temozolomide and Recombinant interferon alfa-2b in people with Malignant Melanoma, run by St. Jude Children's Research Hospital 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?

The sponsor lists 4 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. 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 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?

Yes. Results are posted in the registry (first posted 27 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Tumor Response Rate (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

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 25 Jun 2026.

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