NCT00101972

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 tumor-killing substances to them. PURPOSE: This phase I trial is studying the side effects and best dose of RAV12 in treating patients with metastatic or recurrent adenocarcinoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P50-P75 for phase_1 cancer

Timeline
Completed

Started Dec 2004

Typical duration for phase_1 cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

February 22, 2022

Status Verified

February 1, 2022

Enrollment Period

3.4 years

First QC Date

January 18, 2005

Last Update Submit

February 4, 2022

Conditions

Cancer

Keywords

adenocarcinoma of the bladderadenocarcinoma of the colonadenocarcinoma of the esophagusadenocarcinoma of the extrahepatic bile ductadenocarcinoma of the gallbladderadenocarcinoma of the lungadenocarcinoma of the pancreasadenocarcinoma of the prostateadenocarcinoma of the rectumadenocarcinoma of the stomachadenocarcinoma with squamous metaplasia of the gallbladdercervical adenocarcinomaendometrial adenocarcinomaovarian endometrioid adenocarcinomaovarian undifferentiated adenocarcinomasalivary gland adenocarcinomasmall intestine adenocarcinomavaginal adenocarcinomavaginal clear cell adenocarcinomaovarian clear cell cystadenocarcinomaovarian mucinous cystadenocarcinomaovarian serous cystadenocarcinomastage IV bladder cancerstage IV breast cancerstage IV colon cancerstage IV endometrial carcinomastage IV esophageal cancerstage IV gastric cancerstage IV non-small cell lung cancerstage IV ovarian epithelial cancerstage IV prostate cancerstage IV rectal cancerstage IV renal cell cancerstage IV salivary gland cancerstage IVA cervical cancerstage IVA vaginal cancerstage IVB cervical cancerstage IVB vaginal cancerrecurrent bladder cancerrecurrent breast cancerrecurrent cervical cancerrecurrent colon cancerrecurrent endometrial carcinomarecurrent esophageal cancerrecurrent extrahepatic bile duct cancerrecurrent gallbladder cancerrecurrent gastric cancerrecurrent non-small cell lung cancerrecurrent ovarian epithelial cancerrecurrent pancreatic cancerrecurrent prostate cancerrecurrent rectal cancerrecurrent renal cell cancerrecurrent salivary gland cancerrecurrent small intestine cancerrecurrent vaginal cancerunresectable extrahepatic bile duct cancerunresectable gallbladder cancerstage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • Toxicity by CTCAE

    Days 1-50

Secondary Outcomes (5)

  • Maximum tolerated dose

    Days 1-50

  • Pharmacokinetics of RAV12 by serum levels

    Days 1, 2, 4, 5, 8, 15, 22, 29, 36, 43, and 50

  • Immunogenicity by Human Anti-chimeric antibodies

    Days 1, 8, 15, 22, and 50

  • Time to tumor progression by clinical assessment

    6 months

  • Progression free survival by clinical assessment

    3 and 6 months

Study Arms (1)

RAV12

EXPERIMENTAL
Biological: monoclonal antibody RAV12

Interventions

monoclonal antibody RAV12BIOLOGICAL

Escalating doses of RAV12 (weekly 0.3, 1.0, 1.5, 3.0, 4.0, 5.0, 6.0 mg/kg or 0.5 mg/kg BIW or TIW; 0.75 mg/kg BIW) for 4 weeks

RAV12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

Premiere Oncology

Santa Monica, California, 90404, United States

Location

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

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

Location

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Sarah Cannon Cancer Center at Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

  • Burris HA 3rd, Rosen LS, Rocha-Lima CM, Marshall J, Jones S, Cohen RB, Kunkel LA, Loo D, Baughman J, Stewart SJ, Lewis N. Phase 1 experience with an anti-glycotope monoclonal antibody, RAV12, in recurrent adenocarcinoma. Clin Cancer Res. 2010 Mar 1;16(5):1673-81. doi: 10.1158/1078-0432.CCR-09-2263. Epub 2010 Feb 23.

    PMID: 20179219RESULT

MeSH Terms

Conditions

NeoplasmsColonic NeoplasmsAdenocarcinoma Of EsophagusAdenocarcinoma of LungRectal NeoplasmsUrinary Bladder NeoplasmsBreast NeoplasmsEndometrial NeoplasmsEsophageal NeoplasmsStomach NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Ovarian EpithelialProstatic NeoplasmsCarcinoma, Renal CellSalivary Gland NeoplasmsUterine Cervical NeoplasmsVaginal NeoplasmsBile Duct NeoplasmsGallbladder NeoplasmsPancreatic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsRectal DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUterine DiseasesGenital Diseases, FemaleGenital DiseasesHead and Neck NeoplasmsEsophageal DiseasesStomach DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung DiseasesRespiratory Tract DiseasesOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesKidney NeoplasmsKidney DiseasesMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesUterine Cervical DiseasesVaginal DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract DiseasesGallbladder DiseasesPancreatic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2005

First Posted

January 19, 2005

Study Start

December 1, 2004

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

February 22, 2022

Record last verified: 2022-02

Locations

US(5)