Yttrium Y 90 DOTA Anti-CEA Monoclonal Antibody M5A in Treating Patients With Advanced Solid Tumors

NCT00645060 | Completed Phase 1 DMC

• 4 other identifiers: 05198P30CA033572CHNMC-05198CDR0000590300
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Radiolabeled monoclonal antibodies, such as yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A, can find tumor cells and carry tumor-killing substances to them without harming normal cells. This may be an effective treatment for advanced cancer. PURPOSE: This phase I trial is studying the side effects and best dose of yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A in treating patients with advanced solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (6)

• Maximum tolerated dose

  10 weeks after the beginning of the last cycle of treatment

• Toxicity

  From the date of the beginning of the first cycle of treatment to 10 weeks from the date of the beginning of the last cycle of treatment

• Overall survival

  From 3 months after treatment completion or until death

• Progression-free survival

  From 3 months after treatment completion until cancer progression or start of another treatment

• Time to progression

  3 months and six months after treatment completion until cancer progression or start of another treatment

• Pharmacokinetic and molecular studies

  At 0, 1, 4-6, 12-24, 48, 72-120 and 144-168 hours after administration of the baseline imaging dose

Study Arms (1)

Y-90-DOTA-M5A anti-CEA antibody

EXPERIMENTAL

Other: high performance liquid chromatography; Other: pharmacological study; Procedure: radionuclide imaging; Procedure: single photon emission computed tomography; Radiation: yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A

Interventions

high performance liquid chromatography OTHER

Performed on serial blood samples from 0 to 168 hours and daily X5 days 24 hour urine samples

Y-90-DOTA-M5A anti-CEA antibody

pharmacological study OTHER

Serial blood samples from 0 to 168 hours and daily X5 days 24 hour urine samples

Y-90-DOTA-M5A anti-CEA antibody

radionuclide imaging PROCEDURE

1-3 hours, 1 day, 2 days, 3-5 days and 6-7 days post Y-90 anti-CEA antibody infusion

Y-90-DOTA-M5A anti-CEA antibody

single photon emission computed tomography PROCEDURE

2 days and 3-5 days post antibody infusion

Y-90-DOTA-M5A anti-CEA antibody

yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A RADIATION

Dose escalation from 12 mCi/m2 through 18 mCi/m2 increasing by 2 mCi/m2 with each escalation

Y-90-DOTA-M5A anti-CEA antibody

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed advanced solid tumor for which no standard or effective treatment is available * Patients who refuse an available standard but non-curative treatment may also be eligible * Tumors must produce CEA as documented by either an elevated serum CEA above the upper limit of normal (ULN) or by immunohistochemical (IHC) methods * Positive CEA IHC stain is determined if more than 30% of the tumor cells have an intensity of 2+ or greater * Measurable disease * Estimated \< 1/3 of liver involvement if tumor involves the liver * No brain or leptomeningeal involvement with cancer PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Life expectancy ≥ 3 months * WBC ≥ 4,000/μL * ANC ≥ 1,500/μL * Platelet count ≥ 125,000/μL * Creatinine ≤ 1.5 mg/dL and/or creatinine clearance \> 60 mL/min * Bilirubin ≤ 1.5 mg/dL * ALT and AST ≤ 2 times ULN * Negative pregnancy test * Fertile patients must use effective contraception * Patients currently being treated for severe infections or recovering from other intercurrent illnesses (such as poorly controlled diabetes or hypertension) are ineligible until recovery is deemed complete by the investigator * Serum anti-antibody testing must be negative for human anti-humanized antibodies (if patient received prior monoclonal antibody) * Serum HIV-negative * Serum hepatitis B antigen- and hepatitis C antibody-negative PRIOR CONCURRENT THERAPY: * At least 4 weeks since prior radiotherapy, immunotherapy, or chemotherapy (6 weeks for mitomycin C or nitrosoureas) and recovered * Recovered from prior major surgery * No prior radiotherapy to \> 50% of bone marrow * No other concurrent chemotherapy, radiotherapy, or immunotherapy

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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Interventions

Chromatography, High Pressure Liquid

Intervention Hierarchy (Ancestors)

Chromatography, Liquid; Chromatography; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Jeffrey Y. Wong, MD

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

• Stephen I. Shibata, MD

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 26, 2008
• First Posted: March 27, 2008
• Study Start: October 9, 2006
• Primary Completion: September 6, 2016
• Study Completion: September 6, 2016
• Last Updated: February 27, 2020

Record last verified: 2020-02

Locations

US (1)