A phase II, single arm clinical trial involving an alternative cancer treatment psorinum therapy in patients with metastatic bladder cancer.

Abstract

e15520 Background: We prospectively studied the clinical efficacy of an alternative cancer treatment “psorinum therapy” in treating metastatic bladder cancer (MBC). Methods: Our study was phase II, open level, single arm and single stage. Participants’ eligibility criteria included (1) pathological confirmation of the malignancy (2) metastatic disease status (3) no prior conventional cancer treatments (4) Karnofsky performance status between 40- 70%. The primary outcome measures of the study were (1) to assess the radiological tumor response rate (using CT scanning procedure and following the RECIST criteria); (2) to assess how many participants survived at least 1 yr, 2yrs, 3yrs, 4yrs and finally, after 5 yrs of the study. The secondary outcome measure was to assess the side effects of the investigational anti- cancer drug (psorinum) if any. Psorinum (an alcoholic extract of scabies slough and pus cells) was administered orally at a dose of 0.04ml/ Kg body weight/ day as a single dose on an empty stomach for a complete course duration of 2 yrs to all the participants along with allopathic and homeopathic supportive cares. Results: 72 participants included in the final analysis at the end of the study. According to the RECIST criteria, complete response occurred in 6 (8.33%) cases and partial response occurred in 25 (34.72%) cases. 55 (76.39%) of them survived at least 1yr, 42 (58.33%) survived at least for 2yrs, 28 (38.89%) survived at least 3yrs, 23 (31.94%) survived at least 4yrs, 17 (23.61%) survived at least 5yrs. These participants didn't received conventional or any other investigational cancer treatments. Conclusions: The results of the study show clinical efficacy of psorinum therapy in treating patients with MBC. The investigational drug psorinum is non- toxic. Randomized controlled clinical trial should be conducted for further investigation of this alternative cancer treatment in treating metastatic bladder cancer to integrate it into the mainstream of oncology treatments.