Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed over 18 MSKCC-93081 NCI-V93-0312

Objectives

I.  Estimate the maximum tolerated dose of tecogalan (an angiogenesis 
inhibitor) administered as a twice-weekly infusion for 21 days in patients 
with metastatic cancer.

II.  Assess the qualitative and quantitative toxicities of tecogalan 
administered on this schedule.

III.  Determine the appropriate dose of tecogalan for Phase II clinical trials.

IV.  Characterize the pharmacokinetics/pharmacodynamics of tecogalan.

V.  Evaluate any antitumor effects of tecogalan in this patient population.

Entry Criteria

Disease Characteristics:

Microscopically confirmed, metastatic solid tumor
  No extensive bone metastases
  No leukemia or lymphoma
  AIDS-related Kaposi's sarcoma with at least 10 cutaneous
     lesions and no symptomatic visceral involvement eligible

Disease refractory to known effective therapy or to other
investigational agents with known higher potential activity
  Previously untreated AIDS-related Kaposi's sarcoma eligible

No known or symptomatic CNS involvement (including brain
metastases) unless stable and off therapy

Prior/Concurrent Therapy:

No prior tecogalan

At least 3 weeks since anticancer therapy (6 weeks since
nitrosoureas or mitomycin), and recovered

No concomitant other anticancer therapy or growth factor
support

Patient Characteristics:

Age:
  Over 18

Performance status:
  WHO 0-2

Life expectancy:
  At least 12 weeks

Hematopoietic:
  WBC at least 2,000
  AGC at least 1,200
  Platelets at least 100,000
  Hb greater than 9.0 g/dl

Hepatic:
  Bilirubin no greater than 1.25 x ULN
  Transaminase no greater than 2.0 x normal
  PT and aPTT normal

Renal:
  Creatinine less than 1.25 x ULN OR
  Creatinine clearance at least 60 ml/min
  No indication of active renal disease on urinary sediment
     evaluation

Metabolic:
  Glucose no greater than 280 mg/dl
  Electrolytes normal
  Calcium within 10% of normal
  Phosphorous within 10% of normal
  Uric acid within 10% of normal

Cardiovascular:
  No MI within 6 months
  No uncompensated CHF
  No uncontrolled angina
  No dysrhythmia requiring antiarrhythmics

Other:
  Bone density normal by lateral lumbar spine radiography
     No extensive osteoporosis
  No acute or chronic gastrointestinal bleeding
     Stool guaiac negative for occult blood
  No inflammatory bowel disease
  At least 4 weeks since symptomatic AIDS-defining
     opportunistic infection
  No acute intercurrent infection except genital herpes
  No pregnant or nursing women
     Negative pregnancy test required of fertile women
  Effective contraception required of fertile patients
     Barrier method required for women

Blood/body fluid analyses to determine eligibility and imaging
studies and physical exams for tumor measurement completed
within 14 days prior to registration (ELISA and Western blot
tests may be done at any time prior to treatment); screening
exams (other than blood/body fluid analyses) and imaging
studies of nonmeasurable disease or uninvolved organs completed
within 42 days prior to registration

Expected Enrollment

Approximately 20 patients will be entered over about 1 year.

Outline

Antiangiogenesis Therapy.  Tecogalan Sodium, DS-4152.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Susan Krown, MD, Protocol chair		Ph: 212-639-7426; 800-525-2225 Email: krowns@mskcc.org