Trial record 7 of 364 for:    small cell lung ca | Open Studies

Phase I/II Trial of Rhenium 188-P2045 in Small Cell Lung Cancer and Other Advanced Neuroendocrine Carcinomas

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by New Mexico Cancer Care Alliance
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT02030184
First received: January 6, 2014
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

There are two parts to this trial. The first study will evaluate increasing doses of Re188 P2045 in patients with advanced small cell lung cancer that has recurred after initial therapy or in patients with other advanced neuroendocrine cancers that have progressed after therapy.

Re188 P2045 is designed to attach to type 2 somatostatin receptors that are frequently expressed in those cancers and then the radioactivity from Re188 will kill the cancer cell. Only patients who have cancers that can be seen when Tc99 P2045 is administered (also seeks out the SSTR2, but Tc99 images, but does not treat the cells) will be treated.

Therefore, this approach maximizes the possibility that patients will benefit from treatment in that only those who have cancers that have the target will undergo treatment. The primary purpose of this study will be to determine the highest dose of Re188 P2045 that can be safely administered.

The second study will open after the conclusion of the first. Patients will first undergo the scan with Tc99 P2045 and then be treated with topotecan for three days. Topotecan is a standard chemotherapy drug that is approved for second line therapy for small cell and frequently used for other neuroendocrine cancers. Following that, patients will then be re-evaluated with the Tc99 P2045 scan and if it demonstrates that the tumor is positive for SSTR2, then patients will receive Re188 P2045. The goal of this study is to determine the highest dose of Re188 P2045 that can be safely administered after topotecan as well as to determine if topotecan will increase the chance that the tumor will express SSTR2.


Condition Intervention Phase
Small Cell Lung Cancer (SCLC)
Neuroendocrine (NE) Tumors
Large Cell Neuroendocrine (NE) Tumors
Drug: Rhenium Re 188-P2045
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Dose Escalation Trial of Rhenium 188-P2045 in Small Cell Lung Cancer and Other Advanced Neuroendocrine Carcinomas as a Single Agent and in Combination With Topotecan

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • Determine Maximum Tolerated Dose (MTD) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    To determine, via dose-limiting toxicity (DLT), the maximally tolerated dose (MTD) for Rhenium Re188-P2045 when administered as a single dose in patients with advanced neuroendocrine tumors and SSTR2 expression as determined by Tc99m P2045 scanning.


Secondary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    To describe the overall response rate (ORR) after treatment with Re188 P2045 when administered either as a single dose (Phase I) or following topotecan (Phase II) in patients with advanced neuroendocrine tumors and SSTR2 expression as determined by Tc99m P2045 scanning.

  • Progression Free Survival (PFS) Rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To describe the progression free survival rate (PFS) of survival after treatment with Re188 P2045 when administered as a single dose or following topotecan in patients with advanced neuroendocrine tumors and SSTR2 expression as determined by Tc99m P2045 scanning

  • Change in SSTR2 Expression [ Time Frame: 3 Days ] [ Designated as safety issue: No ]
    To describe the change (if any) in SSTR2 expression, as determined by Tc99m P2045 scanning after topotecan administration.

  • Correlation: Pre-therapy SSTR2 Expression vs. ORR and PFS [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Calculate potential correlation between pre-therapy SSTR2 expression, as determined by Tc99m P2045 imaging, and patient Overall Response Rate (ORR) up to 5 years post treatment. Calculate potential correlation between pre-therapy SSTR2 expression, as determined by Tc99m P2045 imaging, and patient Progression Free Survival (PFS) up to 5 years post treatment.


Estimated Enrollment: 54
Study Start Date: April 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topotecan and Rhenium Re 188 P2045
In the phase II portion of this study, patients will be screened using Technicium Tc99m. Eligible, consented patients will receive Topotecan treatment for three days, at doses of either 1.0 mg/m2 or 1.5 mg/m2. They will then receive a single dose of Rhenium Re 188-P2045, at one of the following dosage levels based on the Phase I Maximum Tolerated Dose (MTD): 40% of MTD; 50% of MTD; 75% of MTD; 85% of MTD or 100% of MTD.
Drug: Rhenium Re 188-P2045
Topotecan at 1.0 mg/m2 or 1.5 mg/m2 for 3 days, followed by single dose of Rhenium Re 188-P2045, at one of the following dosage levels based on the Phase I Maximum Tolerated Dose (MTD): 40% of MTD; 50% of MTD; 75% of MTD; 85% of MTD or 100% of MTD.
Other Name: Study B

Detailed Description:

This trial will be conducted patients with small cell lung cancer and other neuroendocrine cancers. These include extrapulmonary small cell, gastrointestinal carcinoid tumors that arise from pulmonary lesions, and large cell neuroendocrine (NE) tumors.

First, the dose-limiting toxicity (DLT) and maximally tolerated dose (MTD) for Rhenium Re188-P2045 alone will be determined when it is administered as a single dose, at 80, 90, 130, 170, 210 or (up to) 250 mCi/m2.

Subsequently, in the second study Rhenium Re 188-P2045 will be administered at 40, 50, 75, 85 and up to 100 per cent of the MTD determined in the first study, as a single agent or following 3 daily topotecan treatments (at 1.0 or 1.5 mg/m2) in patients with advanced neuroendocrine tumors and SSTR2 expression as determined by Technicium (Tc) Tc99m P2045 scanning.

The overall response and survival rates of patient treated with Rhenium Re188 P2045 when administered as a single dose or following topotecan will be measured.

The change (if any) in SSTR2 expression, as determined by Tc99m P2045 scanning after topotecan administration will also be determined . The correlation of pre-therapy SSTR2 expression (as determined by Tc99m P2045 scan) with overall response and survival rates will be calculated.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >/=18 years.
  • Advanced, metastatic or locally recurrent, incurable neuroendocrine tumors (small cell lung cancer, extrapulmonary small cell lung cancer, large cell neuroendocrine lung carcinoma pulmonary carcinoid, GI carcinoid tumor
  • Symptomatic CNS metastases: must have received therapy (surgery, XRT, gamma knife)
  • Asymptomatic CNS metastatic disease: discuss with Study Chair.
  • Histologically-or cytologically documented disease.
  • Considered incurable by any combination of therapy including surgery, radiation, chemotherapy.
  • ECOG Performance status 0-2
  • Renal function: creatinine clearance > 40 mg/mlxmin (Cockroft-Gault)
  • Adequate organ and marrow function by:
  • Absolute neutrophil count (ANC) >/=1,500/mcL.
  • Platelets >/= 100,000/mcL.
  • Total bilirubin within normal institutional limits (WNL)
  • AST (SGOT)/ALT (SPGT) </= 2.5 x upper limit of normal (ULN)
  • Women (child-bearing potential) and men must use adequate contraception prior to study entry, for duration of study participation, and 90 days after completion of therapy.
  • A female of child-bearing potential is any woman is one who has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 12 consecutive months
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Merkel cell carcinoma
  • Leptomeningeal disease or carcinomatous meningitis
  • Chemotherapy or radiotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered > 3 weeks earlier.
  • If the patient was receiving an oral agent, at least 4 half lives should have elapsed.
  • Cannot receive any other investigational agent at the time of registration. At least 3 weeks should have elapsed since administration of an IV investigational agent or 4 half lives for an oral investigational agent.
  • At least 28 days should have elapsed since administration of a long acting somatostatin analogue.
  • Patients with known brain metastases are eligible (see criteria above). Leptomeningeal metastases are not eligible.
  • Patients who have received external beam radiation to more than 20% of marrow.
  • No prior radiation to the kidneys.
  • Prior systemic radiotherapy are not eligible (except for prior I131 for thyroid cancer more than 1 year earlier).
  • Receiving long term immunosuppressive medications for rheumatologic or other disease (e.g. low dose methotrexate, mecaptopurine etc).
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to octreotide or other somatostatin analogues.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant or nursing (due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02030184

Contacts
Contact: Martin J Edelman, MD 505-272-5490 mjedelman@salud.unm.edu
Contact: Valerie Parks, RN 505-925-0390 vparks@salud.unm.edu

Locations
United States, New Mexico
University of New Mexico Cancer Center Not yet recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Valerie Parks, RN    505-925-0390    vparks@salud.unm.edu   
Principal Investigator: Martin J Edelma n, MD         
Sponsors and Collaborators
New Mexico Cancer Care Alliance
  More Information

Additional Information:
No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT02030184     History of Changes
Other Study ID Numbers: INST 1401
Study First Received: January 6, 2014
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by New Mexico Cancer Care Alliance:
Lung cancer
Small cell lung cancer
Neuroendocrine tumor
Rhenium
Re 188-P2045

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Carcinoma
Carcinoma, Neuroendocrine
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Adenocarcinoma
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014