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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00073892




Registration number
NCT00073892
Ethics application status
Date submitted
10/12/2003
Date registered
11/12/2003

Titles & IDs
Public title
PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma
Scientific title
A Phase I/II Study Of PI-88 In Advanced Malignancies (Phase I), And In Advanced Melanoma(Phase II)
Secondary ID [1] 0 0
CDR0000335412
Secondary ID [2] 0 0
PROGEN-PR88201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma (Skin) 0 0
Unspecified Adult Solid Tumor, Protocol Specific 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PI-88

Experimental: PI-88 - Patients receive four consecutive days treatment each week in a 4-week cycle.


Treatment: Drugs: PI-88
250 mg/day injected subcutaneously on four consecutive days each week in a 4- week cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy Analysis
Timepoint [1] 0 0
end of Cycle 6 of study treatment (24 weeks)
Secondary outcome [1] 0 0
Efficacy Analysis
Timepoint [1] 0 0
were time to progressive disease, survival, duration of partial response, complete response and stable disease

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

Phase I

* Histologically or cytologically confirmed malignancy
* No other effective treatment available OR failed prior therapy
* No prior or concurrent symptomatic or known CNS involvement or brain or meningeal metastases

Phase II

* Diagnosis of stage IV melanoma
* Metastatic disease must be measurable
* No other effective treatment available OR failed prior therapy
* Asymptomatic brain metastases allowed provided patient is off steroids

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2 OR
* Karnofsky 70-100%

Life expectancy

* At least 3 months

Hematopoietic

* Neutrophil count greater than 1,500/mm^3
* Platelet count greater than 100,000/mm^3
* Negative serotonin release assay test for anti-heparin antibodies
* No other abnormal bleeding tendency
* No history of heparin-induced thrombocytopenia
* No history of immune-mediated thrombocytopenia
* No history of thrombolytic thrombocytopenic purpura
* No history of other platelet disease

Hepatic

* Bilirubin less than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 2 times ULN (5 times ULN if liver metastases are present)
* PTT normal (20-34 sec)
* PT less than 1.5 times ULN

Renal

* Creatinine clearance greater than 60 mL/min OR
* Glomerular filtration rate greater than 60 mL/min

Cardiovascular

* No myocardial infarction within the past 3 months
* No stroke within the past 3 months
* No congestive heart failure within the past 3 months

Gastrointestinal

* No history of acute or chronic gastrointestinal bleeding within the past 2 years
* No inflammatory bowel disease

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No AIDS-related illness
* No serious infection within the past 4 weeks
* No history of alcohol, drug, or other substance abuse
* No history of allergy and/or hypersensitivity to anti-coagulants/thrombolytic agents (e.g., heparin)
* No risk of bleeding due to open wounds or planned surgery
* No clinically significant nonmalignant disease
* No uncontrolled infection

Inclusion Criteria

* Current diagnosis of metastatic melanoma, where other effective therapy was not available or had failed.
* Measurable disease. Metastatic lesions had to have been measurable by MRI or CT, and cutaneous lesions by physical examination.
* Biopsiable Lesion Group only: Must have had at least one biopsiable lesion that was bi-dimensionally measurable and previously unirradiated.
* Age= 18 years.
* Have voluntarily given written informed consent to participate in this study.
* Performance status: ECOG 0 - 2 (Karnofsky 70 -100%).
* Life expectancy of at least 3 months.
* Neutrophil count > 1.5 x 109/L (1,500/mm3).
* Platelet count > 100 x 109/L (100,000/mm3).
* APTT normal (20 - 34 sec).
* PT <1.5 x ULN.
* Calculated creatinine clearance, using the Cockcroft-Gault formula, >60 mL/min. If just below 60 mL/min, then GFR>60 mL/min as determined by EDTA or DTPA scan.
* Bilirubin <1.5 x ULN.
* AST and ALT up to 2 x ULN; except in the presence of liver metastases; up to 5 x ULN.
Minimum age
18 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Current symptomatic central nervous system involvement, or active brain or meningeal metastases.
* Concomitant use of aspirin (> 100 mg/day), non-steroidal anti-inflammatory drugs (with the exception of COX-2 inhibitors), heparin, low molecular weight heparin or warfarin (> 1 mg/day) which was ongoing or anticipated during the study period. Low-dose aspirin (100 mg/day or less) or low-dose warfarin (1 mg/day or less) was permitted.
* Heparin or low molecular weight heparin within the previous 2 weeks.
* Chemotherapy, investigational therapy or hormonal therapy in the previous 4 weeks.
* Radiotherapy to a major bone marrow bearing area such as pelvis, femoral heads, lumbar-sacral spine, within the previous 4 weeks. Radiotherapy to other sites within the previous 2 weeks.
* History of allergy and/or hypersensitivity to anti-coagulants/thrombolytic agents, especially heparin.
* History of heparin-induced thrombocytopenia, immune mediated thrombocytopenia, thrombotic thrombocytopenic purpura and/or other platelet diseases, or laboratory evidence of anti-heparin antibodies.
* Myocardial infarction, stroke or congestive heart failure within the previous 3 months
* History of acute or chronic gastrointestinal bleeding within the previous two years, inflammatory bowel disease, any other abnormal bleeding tendency, or patients at risk of bleeding due to open wounds or planned surgery.
* Uncontrolled infection or serious infection within the previous 4 weeks.
* Clinically significant non-malignant disease.
* Known AIDS-related illness or HIV positive.
* Women who were pregnant, breast feeding, or of childbearing potential in whom pregnancy could not be excluded.
* History of abuse of alcohol, drugs or other substances.
* Not recovered from major surgery if conducted prior to the study.

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* More than 4 weeks since prior chemotherapy

Endocrine therapy

* More than 4 weeks since prior hormonal therapy

Radiotherapy

* More than 2 weeks since prior radiotherapy
* More than 4 weeks since prior radiotherapy to a major bone-marrow bearing area (e.g., pelvis, femoral heads, or lumbar-sacral spine)
* Concurrent palliative radiotherapy allowed

Surgery

* Recovered from prior major surgery
* No concurrent surgery

Other

* More than 2 weeks since prior heparin or low-molecular weight heparin
* More than 4 weeks since other prior investigational therapy
* No other concurrent investigational drugs
* No other concurrent antineoplastic therapy
* No concurrent aspirin or aspirin-containing medications
* No concurrent nonsteroidal anti-inflammatory drugs

* Concurrent cyclooxygenase-2 inhibitors allowed
* No concurrent heparin or low-molecular weight heparin
* No concurrent warfarin or warfarin-containing medications
* No other concurrent anticoagulant medications

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2005
Sample size
Target
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [2] 0 0
Queen Elizabeth Hospital - Woodville
Recruitment hospital [3] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Sir Charles Gairdner Hospital - Perth - Perth
Recruitment postcode(s) [1] 0 0
4102 - Brisbane
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cellxpert Biotechnology Corp.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Medigen Biotechnology Corporation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
S. G. Eckhardt, MD
Address 0 0
University of Colorado, Denver
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00073892