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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00539591
First received: October 2, 2007
Last updated: February 26, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Malignant Melanoma
Drug: Peginterferon alpha-2b
Drug: Temozolomide
Drug: Recombinant interferon alpha-2b
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Incorporating Pegylated Interferon In the Treatment For Children With High-Risk Melanoma

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Tumor Response Rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Tumor response rate of stratum B1 participants was evaluated after 1 treatment course of temozolomide plus peginterferon alpha-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.

  • Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Stratum B Patients [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Stratum A Patients [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 29
Study Start Date: October 2007
Estimated Study Completion Date: September 2018
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Temozolomide/peginterferon alpha-2b

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 alpha-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.

Drug: Peginterferon alpha-2b
Given either IV or SQ.
Other Names:
  • PEG-Intron(R)
  • pegylated interferon alpha-2b
Drug: Temozolomide
Given PO.
Other Name: Temodar(R), SCH 52365
Experimental: Peginterferon alpha-2b/non-pegylated interferon alpha-2b
Stratum A: Resected Stages IIC, IIIA, and IIIB patients will receive recombinant interferon alpha-2b 20 million units/m2/day intravenously (IV) 5 consecutive days per week for 4 weeks followed by peginterferon alpha-2b 1mcg/kg subcutaneously (SQ) once a week for 48 weeks.
Drug: Peginterferon alpha-2b
Given either IV or SQ.
Other Names:
  • PEG-Intron(R)
  • pegylated interferon alpha-2b
Drug: Recombinant interferon alpha-2b
Given IV.
Other Names:
  • Intron®
  • non-pegylated interferon alpha-2b

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 alpha-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 alpha-2b and temozolomide.

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

Induction therapy (weeks 1-4): Subjects will receive recombinant interferon alpha-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 alpha-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 alpha-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).
  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539591

Locations
United States, California
Rady Children's Hospital
San Diego, California, United States, 92123
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
The Children's Cancer Hospital at UT M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
St. Jude Children's Research Hospital
Schering-Plough
Investigators
Principal Investigator: Fariba Navid, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00539591     History of Changes
Other Study ID Numbers: MEL06
Study First Received: October 2, 2007
Results First Received: September 10, 2013
Last Updated: February 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Cutaneous Melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Peginterferon alfa-2b
Reaferon
Temozolomide
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Adjuvants, Immunologic
Alcohol Deterrents
Central Nervous System Agents
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on July 26, 2014