Neoplasms

All Conditions

Rare Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

-Cabozantinib 60 mg by mouth daily on days 1-21

Cabozantinib should be taken on an empty stomach (at least 1 hour before or 2 hours after eating) at the same time every day.

Cabozantinib

Baseline, cycle 1 day 8, cycle 1 day 15, and day 1 of every cycle thereafter

Blood for plasma biomarkers

Baseline, before start of cycle 2, and time of progression

Tissue biopsy

Nikolaos Trikalinos, M.D.

Benjamin R Tan, M.D.

Esther Lu, M.S., Ph.D.

Rama Suresh, M.D.

Katrina Pedersen, M.D.

Nusayba Bagegni, M.D.

Ryan Fields, M.D.

Olivia Aranha, M.D., Ph.D.

Patrick Grierson, M.D., Ph.D.

Kian-Huat Lim, M.D., Ph.D.

High grade neuroendocrine neoplasm patients are treated with platinum doublets such as carboplatin and etoposide mimicking the current guidelines for small cell lung cancer (SCLC). Unfortunately, recurrences are common and most patients with metastatic disease succumb to it within a year. There is no extensive literature or consensus on second- or third-line options (which include FOLFOX, FOLFIRI, capecitabine and temozolomide, taxanes or immunotherapy) and there is urgent need for better regimens.

Cabozantinib in High Grade Neuroendocrine Neoplasms

* ORR is defined as number of patients with complete response or partial response
* Complete response - Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level.
* Partial response - At least a 30% decrease in the sum of the diameters of the longest diameter of the target lesions taking as reference the baseline sum longest diameter

-OS is defined as days from date of treatment to date of death. Patients alive or lost to follow-up are censored at the follow-up date.

* PFS is defined as the days from the date of treatment and death or progression, which occurs first. Patients alive without progression or lost to follow-up are censored at the last follow-up date.
* Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of non-target lesions only is exceptional, in such circumstances, the opinion of the treating physician should prevail and the progression status should be confirmed later on by a review panel (or study chair/primary investigator).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cabozantinib in High Grade Neuroendocrine Neoplasms	NCT04412629	High Grade Neur...	Cabozantinib Blood for plasm... Tissue biopsy	18 Years -	Washington University School of Medicine
Cabozantinib in High Grade Neuroendocrine Neoplasms	NCT04412629	High Grade Neur...	Cabozantinib Blood for plasm... Tissue biopsy	18 Years -	Washington University School of Medicine

Spots Global Cancer Trial Database for high grade neuroendocrine neoplasms