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Phase II Study of Low Dose Peginterferon Alfa-2b in Patients With Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma (Skin)

Thank you

Trial Information

Phase II Study of Low Dose Peginterferon Alfa-2b in Patients With Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor


OBJECTIVES:

- Determine the ability of low-dose PEG-interferon alfa-2b to suppress plasma basic
fibroblast growth factor (b-FGF) levels to normal in patients with metastatic melanoma
over-expressing b-FGF.

- Determine the antitumor effect of this drug, in terms of progression-free and overall
survival and tumor response, in these patients.

- Correlate tumor activity of this drug with b-FGF and vascular endothelial growth factor
levels in the plasma and urine of these patients.

- Determine the safety profile of this drug in these patients.

OUTLINE: This is a multicenter study.

- Induction: Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly.
Treatment continues until basic fibroblast growth factor level is suppressed to normal
or until a maximum weekly dose is reached. If there is no disease progression, patients
then proceed to maintenance.

- Maintenance: Patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the
absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage IV melanoma

- Stage M1a, M1b, or M1c

- Mucosal, ocular, or unknown primary melanoma

- Previously untreated OR received up to 3 prior systemic therapy regimens (excluding
vaccine therapy) for metastatic disease

- Plasma basic fibroblast growth factor level at least 15 pg/mL

- Measurable or evaluable disease

- CNS involvement allowed provided CNS directed therapy has been given and disease has
been clinically stable for ≥ 3 months

- Brain CT scan or MRI to confirm stable disease required ≤ 4 weeks prior to study
entry

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 6 months

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 8 g/dL (transfusions allowed)

Hepatic

- Bilirubin no greater than 2 times upper limit of normal (ULN)

- ALT no greater than 2 times ULN

Renal

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min

Cardiovascular

- No myocardial infarction within the past 6 months

Other

- No other active malignancy within the past 5 years except curatively treated basal
cell or squamous cell skin cancer or carcinoma in situ of the cervix

- No other concurrent illness that would preclude study participation

- No history of severe depression

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 4 weeks since prior interferon in the adjuvant or metastatic setting

Chemotherapy

- At least 4 weeks since prior chemotherapy in the adjuvant or metastatic setting

Endocrine therapy

- At least 4 weeks since prior endocrine therapy in the adjuvant or metastatic setting

Radiotherapy

- At least 4 weeks since prior radiotherapy in the adjuvant or metastatic setting

Surgery

- At least 4 weeks since prior surgery in the adjuvant or metastatic setting

Other

- At least 4 weeks since other prior therapy in the adjuvant or metastatic setting

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Suppression of plasma basic fibroblast growth factor (b-FGF) level as measured by ELISA every 3-6 weeks

Safety Issue:

No

Principal Investigator

Ronald S. Go, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gundersen Lutheran Center for Cancer and Blood

Authority:

United States: Federal Government

Study ID:

CDR0000258114

NCT ID:

NCT00049530

Start Date:

September 2003

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • recurrent melanoma
  • stage IV melanoma
  • Melanoma

Name

Location

CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Aultman Cancer Center at Aultman HospitalCanton, Ohio  44710-1799
MetroHealth Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44109
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Swedish-American Regional Cancer CenterRockford, Illinois  61104-2315
West Virginia University Health Sciences Center - CharlestonCharleston, West Virginia  25302
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Lakeland Regional Cancer Center at Lakeland Regional Medical CenterLakeland, Florida  33805
UPMC Cancer CentersPittsburgh, Pennsylvania  15232
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Mason District HospitalHavana, Illinois  62644
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
UAB Comprehensive Cancer CenterBirmingham, Alabama  35294
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Galesburg Clinic, PCGalesburg, Illinois  61401