LAnreotide in Metastatic Pheochromocytoma / PARAganglioma (LAMPARA) (LAMPARA)
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|ClinicalTrials.gov Identifier: NCT03946527|
Recruitment Status : Not yet recruiting
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
The objectives of this study are:
- To assess the efficacy of lanreotide given every 4 weeks in participants with advanced or metastatic paraganglioma/ pheochromocytoma.
- To assess the toxicity and safety of lanreotide in participants with advanced or metastatic paraganglioma/ pheochromocytoma.
- To document the effects of lanreotide on markers of biochemical activity in participants with advanced or metastatic paraganglioma/ pheochromocytoma.
• Assess efficacy by estimating the tumor growth rate while a patient is enrolled on study and comparing the growth rates on lanreotide to the pre-enrolment growth rate.
Secondary endpoints include measurement of:
- Overall survival (OS)
- Progression-free survival (PFS)
- Overall response rate (ORR) according to RECIST defined as partial response (PR) + complete response (CR)
- Magnitude of reduction in levels of 24-hour urinary metanephrines, catecholamines and magnitude of reduction in serum chromogranin A, evaluated every two months while enrolled on study.
|Condition or disease||Intervention/treatment||Phase|
|Paraganglioma Pheochromocytoma||Drug: Lanreotide||Phase 2|
Lanreotide is FDA approved for certain kinds of neuroendocrine tumors. This study seeks to determine if lanreotide is beneficial for patients with paraganglioma/ pheochromocytoma.
Given the rarity of pheochromocytoma/paraganglioma that precludes the conduct of a randomized clinical trial in a timely manner, a novel method for assessing efficacy is being proposed. Efficacy will be assessed by estimating the tumor growth rate while a patient is enrolled on study and comparing the growth rates on lanreotide to the pre-enrollment growth rates. The method of analysis that will be used has been previously described. For this assessment a minimum of three tumor measurements will be required.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exploratory Phase II Study of LAnreotide in Metastatic Pheochromocytoma/PARAganglioma (LAMPARA)|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: lanreotide arm
Patients with a histopathologically confirmed diagnosis of malignant paraganglioma or pheochromocytoma and either evidence of metastases or unresectability who meet the inclusion/exclusion criteria. Approximately 40 patients will be enrolled.
Participants will receive lanreotide 120 mg deep subcutaneous injection every 4 weeks (±7 days) for 52 weeks, followed by an extension phase in which all patients will continue to receive lanreotide 120 mg injection every 4 weeks (±7 days) if there is no evidence of disease progression.
Other Name: Somatuline Depot
- Rate of tumor growth [ Time Frame: minimum of 32 weeks, up to 48 weeks ]Efficacy will be assessed by measuring the tumor growth rate while a patient is enrolled on study and comparing the growth rates on lanreotide to the pre-enrollment growth rates. Tumor growth measured by a CT or MRI scan in pre-treatment, and minimum of three scans (prior to every 3rd visit, or every 12 weeks) in post-treatment.
- Overall survival (OS) [ Time Frame: Observed for 48 weeks (start of treatment to end of treatment). ]The length of time from the start of treatment that subjects with the disease are still alive.
- Overall Response Rate (ORR) [ Time Frame: Minimum of 8 weeks, up to 48 weeks. ]
ORR is defined as the proportion of the subjects in the analysis population who have a complete response (CR) or partial response (PR). Responses are based on assessments per RECIST 1.1. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria.
- Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than 10 mm.
- Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- Progression-free survival [ Time Frame: Up to 48 weeks. ]PFS is defined as the time from the first day of treatment to the first documented disease progression per RECIST 1.1 criteria and the Kaplan-Meier curve. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria.
- Magnitude of reduction in analyte levels [ Time Frame: Minimum of 16 weeks, up to 48 weeks. ]Biochemical response of greater than 20% drop in 24-hour urinary metanephrines, catecholamines and serum chromogranin A levels compared to baseline, sustained for >12-week-period. Evaluated every two months while enrolled on study, although levels may be obtained as frequently as the investigator desires.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03946527
|Contact: Lisa Olmos, RNfirstname.lastname@example.org|
|Contact: Antonio Fojo, MD, PhDemail@example.com|
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Contact: Antonio Fojo, MD, PhD 212-305-9422 firstname.lastname@example.org|
|Principal Investigator: Antonio Fojo, MD, PhD|
|Principal Investigator:||Antonio Fojo, MD, PhD||Columbia University|