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Status:

COMPLETED

RAV12 in Treating Patients With Metastatic or Recurrent Adenocarcinoma

Lead Sponsor:

MacroGenics

Conditions:

Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

RATIONALE: Monoclonal antibodies, such as RAV12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry...

Detailed Description

OBJECTIVES: * Determine the maximum tolerated dose of RAV12 in patients with metastatic or recurrent adenocarcinoma. * Determine the toxicity profile of this drug in these patients. * Determine the p...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed adenocarcinoma
  • Metastatic or recurrent disease
  • Not curable by standard therapies
  • Must have failed at least 1, but no more than 3, prior therapies for metastatic or recurrent disease
  • Patients with colorectal or breast adenocarcinoma must have failed at least 2 prior therapies
  • Must have had at least stable disease for 3 months while on last treatment prior to most recent disease progression
  • Meets 1 of the following criteria:
  • At least 1 measurable site of disease ≥ 2 cm by radiography
  • Evaluable disease that could be reliably and consistently followed, as deemed by the principal investigator
  • RAAG12 expression confirmed\* by immunohistochemistry NOTE: \*Not required for patients with colon, pancreatic, or gastric adenocarcinoma
  • No evidence of residual or recurrent CNS metastases
  • Hormone receptor status:
  • Not specified
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Sex
  • Not specified
  • Menopausal status
  • Not specified
  • Performance status
  • ECOG 0-1
  • Life expectancy
  • More than 3 months
  • Hematopoietic
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 9.0 g/dL (transfusions allowed)
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Hepatic
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • γ-glutamyl transferase ≤ 2.5 times ULN
  • Adequate hepatic function sufficient to undergo study therapy
  • Renal
  • Creatinine \< 1.5 mg/dL
  • Adequate renal function sufficient to undergo study therapy
  • Cardiovascular
  • No New York Heart Association class III or IV heart disease
  • No thrombosis within the past 3 months, including any of the following:
  • Deep vein thrombosis
  • Myocardial infarction
  • Stroke
  • Adequate cardiac function sufficient to undergo study therapy
  • Pulmonary
  • No pulmonary embolism within the past 3 months
  • No significant pulmonary compromise, particularly dependence on supplemental oxygen on an as-needed or continuous basis
  • Adequate pulmonary function sufficient to undergo study therapy
  • Immunologic
  • No active viral, bacterial or systemic fungal infection requiring parenteral therapy within the past 4 weeks
  • No history of chronic or recurrent infection requiring continual antiviral, antifungal, or antibacterial agents
  • No known hypersensitivity to murine or recombinant proteins, polysorbate 80, or any excipient contained in study drug
  • Other
  • Amylase and lipase normal
  • No other primary malignancy within the past 3 years except for the following:
  • Treated non-melanoma skin cancer
  • Carcinoma in situ of the cervix by biopsy
  • Squamous intraepithelial lesion of the cervix by PAP smear
  • Localized prostate cancer (Gleason score \< 6)
  • Resected melanoma in situ
  • No other serious medical condition that would preclude study participation
  • No dementia or altered mental status that would preclude giving informed consent
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • At least 3 half-lives since prior monoclonal antibody therapy
  • No concurrent vaccinations
  • No concurrent prophylactic hematologic growth factors
  • Chemotherapy
  • At least 4 weeks since prior chemotherapy
  • Endocrine therapy
  • No concurrent steroids except for the following:
  • Inhaled, ophthalmic, or nasal steroids
  • Stable dose of oral prednisone (or equivalent) ≤ 10 mg/day
  • Radiotherapy
  • At least 4 weeks since prior radiotherapy
  • Surgery
  • More than 4 weeks since prior major surgery
  • Other
  • More than 4 weeks since prior investigational agents
  • Prior oral antiviral, antifungal, or antibacterial therapy allowed provided therapy was completed within the past week
  • No other concurrent antineoplastic therapy
  • No concurrent immunosuppressive medications
  • No other concurrent investigational agents
  • No concurrent vitamins except those approved by the medical monitor
  • Concurrent daily multivitamin allowed
  • Concurrent bisphosphonates allowed provided patient is on stable dose for ≥ 1 month prior to study entry

Exclusion

    Key Trial Info

    Start Date :

    December 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 1 2008

    Estimated Enrollment :

    53 Patients enrolled

    Trial Details

    Trial ID

    NCT00101972

    Start Date

    December 1 2004

    End Date

    May 1 2008

    Last Update

    February 22 2022

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Premiere Oncology

    Santa Monica, California, United States, 90404

    2

    Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, United States, 20007

    3

    University of Miami Sylvester Comprehensive Cancer Center - Miami

    Miami, Florida, United States, 33136

    4

    Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, United States, 19111-2497