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A Phase I Single Dose-Escalation Study of BIBH-1 in Patients With Colorectal Cancer Scheduled for Surgical Resection

Phase 1
18 Years
Not Enrolling
Colorectal Cancer, Metastatic Cancer

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Trial Information

A Phase I Single Dose-Escalation Study of BIBH-1 in Patients With Colorectal Cancer Scheduled for Surgical Resection

OBJECTIVES: I. Determine any toxicity associated with increasing single doses of monoclonal
antibody F19 (BIBH-1) administered by intravenous infusion in patients with colorectal
cancer scheduled for surgical resection. II. Compare the pharmacokinetics, biodistribution,
and imaging characteristics of increasing intravenous doses of iodine I 131 BIBH-1 in this
patient population. III. Compare the BIBH-1 related human antihuman antibody (HAHA) serum
concentration with immunologic related clinical effects in these patients. IV. Compare the
uptake of iodine I 131 BIBH-1 in tumor to the uptake of normal tissue when administered to
these patients.

OUTLINE: This is a dose escalation study. Patients receive monoclonal antibody F19 (BIBH-1)
combined with iodine I 131 IV over 60 minutes. Patients undergo surgical resection
approximately 7 days after BIBH-1 infusion. Cohorts of 3-6 patients receive escalating doses
of BIBH-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Patients
are followed once during days 5-14 and then at day 30 after surgery.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 4 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed primary colorectal cancer Candidate for
a clinically indicated laparotomy for primary tumor resection, resection of hepatic
metastases, or placement of an intrahepatic arterial catheter No active CNS metastases
defined by new or enlarging lesions on CT scan or within 3 months of treatment (i.e.,
surgery or radiotherapy) for brain metastases No prior participation in this study

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: At least 3 months Hematopoietic: Granulocyte count at least 2,500/mm3
Lymphocyte count greater than 700/mm3 Platelet count at least 100,000/mm3 Hepatic: ALT/AST
no greater than 3 times upper limit of normal Bilirubin less than 2 mg/dL Renal:
Creatinine no greater than 2.0 mg/dL Other: No pregnant or nursing Negative pregnancy test
Fertile patients must use effective contraception No incomplete healing at an incision
site as evidenced by incomplete granulation, infection, or localized edema No active
infections requiring antibiotics No bleeding disorders No other serious illness that may
potentially interfere with obtaining accurate study results No autoimmune disease No
hypertrophic skin conditions

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy No
prior murine, chimeric, or humanized antibody and/or antibody fragment Chemotherapy: At
least 4 weeks since prior chemotherapy Endocrine therapy: No concurrent systemic
corticosteroids except for acute management of allergic type events Radiotherapy: See
Disease Characteristics Surgery: See Disease Characteristics Recovered from prior surgery
Other: At least 4 weeks since other prior investigational agents No concurrent
immunosuppressive agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Sydney Welt, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

September 1999

Completion Date:

August 2000

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • stage I colon cancer
  • stage II colon cancer
  • stage III colon cancer
  • stage IV colon cancer
  • stage I rectal cancer
  • stage II rectal cancer
  • stage III rectal cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • liver metastases
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Memorial Sloan-Kettering Cancer Center New York, New York  10021