search
Back to results

ISIS 3521 in Treating Patients With Advanced, Unresectable, or Metastatic Non-small Cell Lung Cancer or Unresectable or Metastatic Melanoma

Primary Purpose

Lung Cancer, Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ISIS 3521
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 treatment

Sites / Locations

  • Universitaetsklinik
  • Kaiser Franz Josef Hospital
  • Institut Jules Bordet
  • Ludwig Institute for Cancer Research-Brussels Branch
  • Universitair Ziekenhuis Antwerpen
  • U.Z. Gasthuisberg
  • Herlev Hospital - University Hospital of Copenhagen
  • Centre Jean Perrin
  • Centre Leon Berard
  • CRLCC Nantes - Atlantique
  • Institut Claudius Regaud
  • Institut Gustave Roussy
  • Universitaetsklinik und Strahlenklinik - Essen
  • Klinikum Nurnberg
  • Academisch Ziekenhuis der Vrije Universiteit
  • Antoni van Leeuwenhoekhuis
  • Academisch Ziekenhuis Groningen
  • St. Radboud University Hospital
  • Rotterdam Cancer Institute
  • Norwegian Radium Hospital
  • University Hospital
  • Inselspital, Bern
  • Kantonsspital - Saint Gallen
  • Newcastle General Hospital
  • Ninewells Hospital and Medical School
  • Western General Hospital
  • C.R.C. Beatson Laboratories

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
July 10, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
search

1. Study Identification

Unique Protocol Identification Number
NCT00003989
Brief Title
ISIS 3521 in Treating Patients With Advanced, Unresectable, or Metastatic Non-small Cell Lung Cancer or Unresectable or Metastatic Melanoma
Official Title
Phase II Trial With ISIS 3521/CGP 64128A in Patients With Malignant Melanoma and Non Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
June 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ISIS 3521 in treating patients who have advanced, unresectable, or metastatic non-small cell lung cancer or unresectable or metastatic melanoma.
Detailed Description
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 study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Melanoma (Skin)
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
ISIS 3521

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shoshana Kaplan, MD
Organizational Affiliation
Universitaetsspital-Basel
Official's Role
Study Chair
Facility Information:
Facility Name
Universitaetsklinik
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Kaiser Franz Josef Hospital
City
Vienna (Wien)
ZIP/Postal Code
A-1100
Country
Austria
Facility Name
Institut Jules Bordet
City
Brussels (Bruxelles)
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Ludwig Institute for Cancer Research-Brussels Branch
City
Brussels (Bruxelles)
ZIP/Postal Code
B-1200
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Herlev Hospital - University Hospital of Copenhagen
City
Herlev
ZIP/Postal Code
DK-2730
Country
Denmark
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
CRLCC Nantes - Atlantique
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Facility Name
Universitaetsklinik und Strahlenklinik - Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany
Facility Name
Klinikum Nurnberg
City
Nuremberg (Nurnberg)
ZIP/Postal Code
D-90419
Country
Germany
Facility Name
Academisch Ziekenhuis der Vrije Universiteit
City
Amsterdam
ZIP/Postal Code
1007 MB
Country
Netherlands
Facility Name
Antoni van Leeuwenhoekhuis
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Academisch Ziekenhuis Groningen
City
Groningen
ZIP/Postal Code
9713 EZ
Country
Netherlands
Facility Name
St. Radboud University Hospital
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Rotterdam Cancer Institute
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
N-0310
Country
Norway
Facility Name
University Hospital
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Inselspital, Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Kantonsspital - Saint Gallen
City
Saint Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland
Facility Name
Newcastle General Hospital
City
Newcastle Upon Tyne
State/Province
England
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Ninewells Hospital and Medical School
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 9NQ
Country
United Kingdom
Facility Name
C.R.C. Beatson Laboratories
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G61 1BD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

ISIS 3521 in Treating Patients With Advanced, Unresectable, or Metastatic Non-small Cell Lung Cancer or Unresectable or Metastatic Melanoma

We'll reach out to this number within 24 hrs