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Phase II Trial With ISIS 3521/CGP 64128A in Patients With Malignant Melanoma and Non Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer, Melanoma (Skin)

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Trial Information

Phase II Trial With ISIS 3521/CGP 64128A in Patients With Malignant Melanoma and Non Small Cell Lung Cancer

OBJECTIVES: I. Determine the complete and partial response rates and duration of response in
patients with locally advanced, unresectable, or metastatic non-small cell lung cancer or
unresectable or metastatic melanoma treated with ISIS 3521. II. Determine safety of ISIS
3521 in these patients.

OUTLINE: This is a multicenter study. Patients are stratified by disease type. Patients
receive ISIS 3521 IV over 21 days followed by 7 days of rest. Courses repeat every 28 days
in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 28-50 patients (14-25 per stratum) will be accrued for this

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven melanoma that is
unresectable and regionally metastatic, or widely disseminated OR Histologically or
cytologically proven non-small cell lung cancer (NSCLC) that is locally advanced,
unresectable, or metastatic Stage IIIA, IIIB, or IV Evidence of disease progression prior
to study At least 1 bidimensionally measurable lesion The following are NOT considered
measurable: previously irradiated lesions, ascites, pleural effusion, bone metastases,
brain metastases, leptomeningeal disease, or an abdominal mass that can be palpated but
not measured Melanoma patients whose only manifestation of disease is 1 of the following
are NOT eligible: Lymphedema Pleural effusion Ascites CNS metastases Bone marrow
infiltration Osteoblastic bone lesions

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At
least 3 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least
100,000/mm3 No abnormal clotting tests Hepatic: Bilirubin no greater than 2.0 mg/dL AST
and ALT no greater than 2 times upper limit of normal (ULN) (5 times ULN if due to liver
metastases) Renal: Creatinine no greater than 1.6 mg/dL OR Creatinine clearance at least
60 mL/min Urinary protein less than 0.3 g/dL Cardiovascular: No superior vena cava
obstruction in NSCLC unless successfully treated at least 2 months prior to study Other:
No underlying disease state associated with active bleeding No prior or concurrent
malignancies at other sites except adequately treated cone biopsied carcinoma in situ of
the cervix uteri or basal cell or squamous cell skin cancer No nonmalignant systemic
disease making patient poor risk for study No active uncontrolled infection Not pregnant
or nursing Negative pregnancy test Fertile patients must use effective contraception
during and for 3 weeks after study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy
(including interferon or interleukin-2) for melanoma patients No other concurrent
anticancer immunotherapy Chemotherapy: No prior chemotherapy for melanoma patients except
adjuvant or local chemotherapy (extracorporeal circulation) At least 4 weeks since prior
adjuvant or local chemotherapy if presence of measurable lesions outside the treated limb
(6 months if no presence of measurable lesions outside the treated limb) No prior
chemotherapy for NSCLC except platinum compounds used as radiosensitizer At least 4 weeks
since prior platinum compounds No other concurrent anticancer chemotherapy Endocrine
therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Concurrent
radiotherapy allowed for bone pain or other reasons No irradiation of all evaluable
lesions Surgery: See Disease Characteristics Other: At least 4 weeks since other prior
investigational drugs No other concurrent investigational drugs No concurrent
anticoagulants except heparin used to prevent occlusion of IV lines during week(s) off

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Shoshana Kaplan, MD

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Federal Government

Study ID:




Start Date:

June 1998

Completion Date:

Related Keywords:

  • Lung Cancer
  • Melanoma (Skin)
  • recurrent non-small cell lung cancer
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Melanoma