A Phase II Study of EC17 (Folate-hapten Conjugate) in Patients With Progressive Metastatic Renal Cell Carcinoma

NCT00485563 | Terminated Phase 2

• 1 other identifier: EC-FI-004
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

This is a Phase 2 clinical trial to collect data on tumor responses produced by folate-hapten conjugate therapy (vaccination with EC90 \[KLH-FITC\] and GPI-0100 adjuvant followed by treatment with EC17 (folate-FITC) in combination with low-dose cytokines in patients with progressive metastatic renal cell carcinoma. All patients will undergo imaging with the investigational imaging agent 99mTc-EC20 (FolateScan) during the screening period to confirm eligibility for the treatment portion of the clinical trial.

Conditions

Renal Cell Carcinoma

Keywords

Cancer; Vaccine; Phase 2; folate-hapten conjugate; Progressive; Metastatic; Experimental

Outcome Measures

Primary Outcomes (1)

• Response Rate - the proportion of subjects with objective response based on RECIST criteria

  A minimum of 13 weeks (time to first follow-up CT)

Secondary Outcomes (3)

• To assess the safety and tolerability of folate-hapten conjugate therapy

  Duration of study drug administration + 30 days

• Time-to-progression, response duration, overall survival time observed after folate-hapten conjugate therapy and ECOG performance status

  Up to 2 years following completion of therapy

• To assess the safety and tolerability of 99mTc-EC20

  Duration of study drug administration + 7 days

Interventions

EC90 (KLH-FITC) BIOLOGICAL

1.2mg in combination with adjuvant GPI-0100 administered subcutaneously (beneath the skin) weekly for 4 consecutive weeks during the first cycle of treatment, weekly for 2 consecutive weeks during the second cycle and once for each additional cycle.

Also known as: Keyhole limpet hemocyanin fluorescein

GPI-0100 BIOLOGICAL

3.0 mg in combination with EC90 administered subcutaneously weekly for 4 consecutive weeks during the first cycle of treatment, weekly for 2 consecutive weeks during the second cycle and once for each additional cycle.

Also known as: Saponin-based adjuvant

EC17 (Folate-FITC) DRUG

0.3mg/kg administered subcutaneously 5 days per week (Monday through Friday) for 4 consecutive weeks for the first two treatment cycles and then 3 days per week (Monday, Wednesday, Friday) for 3 consecutive weeks for each additional cycle.

Also known as: folate-fluorescein conjugate;, folate-hapten conjugate

Interleukin-2 DRUG

7.0 MIU administered subcutaneously 3 times per week (Monday, Wednesday, Friday) for 4 consecutive weeks during the first 2 cycles of treatment, then 2.5 MIU administered subcutaneously 3 times per week (Monday, Wednesday, Friday) for 3 consecutive weeks for each additional cycle.

Also known as: IL-2, Proleukin

Interferon-alpha DRUG

3.0 MIU administered subcutaneously 3 times per week (Monday, Wednesday, Friday) for 4 consecutive weeks during the first 2 cycles of treatment, then 3.0 MIU administered subcutaneously 3 times per week (Monday, Wednesday, Friday) for 3 consecutive weeks for each additional cycle.

Also known as: IFN-alpha, Intron-A

Eligibility Criteria

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

You may qualify if:

• Must have a histologically confirmed diagnosis of renal cell carcinoma (clear cell or predominately clear cell component). Papillary histology may also be enrolled (maximum of 6 patients)
• Must be diagnosed with relapsed or Stage IV disease that is medically or surgically unresectable and that has progressed after systemic therapy, including at least one agent in the general class of kinase inhibitors (TKI not required for papillary histology)
• Must have measurable/evaluable metastatic disease sites that have not previously received radiotherapy and which does not require palliative intervention (at the time of enrollment). Patients with non-measurable/evaluable disease are ineligible
• Must have at least one tumor lesion that displays uptake of 99mTc-EC20
• Must be \> than or = 18 years of age
• Women must either be 1)not of child-bearing potential of 2)have a negative serum pregnancy test within 7 days prior to commencing treatment with investigational agents
• Must have completed prior cytotoxic chemotherapy, radiotherapy, immunotherapy or experimental therapy 30 or more days prior to study enrollment, and recovered (or returned to baseline) from associated acute toxicities. This restriction excludes palliative radiotherapy.
• Must have an ECOG score less than or equal to 2
• Must have adequate hematologic, renal, and heptic function

You may not qualify if:

• Must not have a history of severe hypersensitivity (grade 3 - 4 allergic reaction) to fluorescein, radiological contrast agent, cytokines, or have received fluorescein within 30 days of the study
• Must not have medical conditions that preclude the use of IL-2 or IFN-α.
• Must not be pregnant or breast-feeding
• Must not be currently undergoing chemotherapy, anticancer hormonal therapy, and/or therapy with immunosuppressant agents
• Must not be currently receiving bisphosphonates such as Zometa® (unless started \> four weeks prior to treatment with EC90/GPI-0100, in which case they can be continued)
• Must not have any concomitant malignancy with the exception of basal cell or squamous cell carcinoma of skin
• Must not have radiographically documented evidence of current brain metastases, a history of stem cell transplant, immunodeficiency, and/or a medical or psychiatric illness (that in the investigator's opinion, would prevent adequate compliance with study therapy or evaluation of the endpoints)
• Must not have been administered another radiopharmaceutical that would interfere with the assessment of 99mTc-EC20
• Must not be unable to tolerate conditions for radionuclide imaging

Sponsors & Collaborators

• Endocyte: lead

Study Sites (3)

University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasms; Neoplasm Metastasis

Interventions

fluorescein isothiocyanate-keyhole limpet hemocyanin; GPI0100; Interleukin-2; aldesleukin; Interferon-alpha; Introns

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Interferon Type I; Interferons; DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes

Study Officials

• Richard A Messmann, MD, MHS, BSc

  Endocyte

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2007
• First Posted: June 13, 2007
• Study Start: June 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: March 1, 2009
• Last Updated: March 8, 2012

Record last verified: 2012-03

Locations

US (3)